Clinical trial: NCT04081688
Section: Alternatives
Subsections: Whnt Rre Tle Possible Benelits Of Sample Banking?

you will uot beuefit personally &om providing samples for this tissue bank because research usually takes a long time to produce rueaningfiil results. However, yotu participation may help investigators understand, prevent. or heat the diseases and couditions studied iu the fuhue-
Is there other importont information to ronsider?  
Yes. There is no cost to you to allow us to store and use your tissue and ioformation for future research. Nor will you be paid to participate in this repository. Should any products or senrices result from rer.rr.L using yoru samples and information, there is no plan to sharc any of the profits with you.  
The research we are doing is only a stepping stone in trnderstandilg disease. It may take a loug time for our researth to pioduce tsefirl health-related informatioo. Thercfore, tests done for olu' research using your samples and infonnation will not be usefirl in dilecting your nredical care" Infonnation from orr reiearch will not be rehrned to you, yout family members, yotu doctor, or outside p*rties. It is possible, Ito@ arrthorifies. such as the U.S.  
Food and Dnrg Administratiotl, Review Board, or other persors required by law may be a Are there *ny costs or ptyilents for sample banking?  
There is no cost to you to allow trs to store aud use your tissue aud information for firhue research. Nor will you he paid to participate in this repository. Should any products or services result from.*.***L using yoru samptes aud information, there is no plau to share any of the profits withyou.  
Iyhat *rc your rights ifyou agree tq the storage snd use ofyour tissue for future resenrch?  
You gnderstand that you have the riglrt to ask questious about any part of ttrre futtura study at any tirne. Yotr rurderstand that you shouta not sign-this forur mrless you have had a chance to ask questions and have beet given arswers to all of yotr questions.  
Yoru participation in this part of the study is vokmtary. You do not have to you cau change your miud at any time.  
I
ICF vcrsion 3i23!2022 Aruroval Datfr Expiration Date Authoriz*tion to use your health information for future research purposes Becalse infonlation uilo* you ard yolu'health is personal and privcte, it gelerally carulot be trsed iu this ftlhre research rt rdi"r without yo*'*ritt"o authorization (permission)- If you sigp this addenduu consent below, it will provide that authorization.  
Makingyour choice:
My bbd and related information may be collected and stored in the biorepository for use i[
futu:e health cancer-related research.  
(subject's initials)  
Yes  
  
(subject's initials)
No
My hrmor tissue samples and related information uray be kept iu the biorepository for use iu fuhre cancer-related research.  
(suhject's initials)
Yes No
(subject's initials)
\ilhat if I chauge my mind apgg If vou wish to take part in the any rernainirg tissue to stored in the repository.  
However, please note that it may not be possible to destroy sarnples, inform,ation and data crcated frour that been used ito lVhat if I hnve more questions about sample banking?  
If yotr have questions a-bou1fhqgsg o:frou saurples for research, contact the study doctor, about the use of Authorization to use your hedth information for future resesrch purposes Becalse information alout you and yoru health is persoual aud private, it geuerally cannot be used in this fuhge research itrdi"r without yoru writteu authorization fuerurissiou), If you sign this adderdurn consent form, it will provide that authorization. The details of what inforuration we will collect and how we will use it are discussed in the tnain consettt tmder the heading,
..AUTHORTZATION TO USE YOUR HEALTH INFORMATION FOR RESEARCH
PURPOSES" near the end of the main consent documeat.  
Thaok you for consideriug parlicipation in this research-
This is the end of the section about additional studies'
Clinical trial: NCT04081688
Section: Confidentiality
Subsections: For Non.English.Spea'King Subjects: Signeture Of Reader/Tr*Uslator If The Subject Does Not Read English Lyell:|Ifow And Where Will Your Tissue And Health Informrtion Be Stored And By Whom?

The person who has sigued the short fonn, does not read English well. You read English well and are fluent in (narue of the language), a lanpprage thatihe subject (his/her pareut(s)/legal pnrardian) rmdetstands.well. Yott
.*j""rtarrd the conteut of this consent fonn and you have translated for the subject (his/her par.elt(s)ltegal guar.diaa) the eutile coiltent of this fonn. To the best of yotu knowledge' the r,rt;""i (his/lrer parent(siAegal guardian) understands the content of this for:n aad has had au opport*lty to ask qo**tiooi'r.lardnrg tLe consent fonu and the sttdy, and these questions have been answered (hisflrer parent(s)llegal guardian)-
Reader/Translator Narne ; Reader/Translator Sipmafure :
Witness Name:

Information obtained from this research with material obtained from yoru blood or tissue sample(s) will be kept confidential so that neither the investigator nor the Sponsor can link your furdividual research results with your ideutity' your-sample(s), aod materials derived fi'om you saurple(s), will be given a code ntuuber, aod only informaiion retated to your age! sex! race, health condition and other:relevaut clinical information collected in themain study will be linked with the sample's code nuaber- Yotu rumre. date of bifih, address, or other personal ideutiSing iufonnation, will not be linked with the sample(s) you give.
Clinical trial: NCT04081688
Section: Duration of Study Involvement
Subsections: Follow-Up

If y"" Ir"* auy ongoing side effects at the time you complete the study or yourdoctor discontinues you frr, tne iuOv]tfeitudy doctor will continue to follow your conditiou until the side effect resolves or becomes stable.  
If you1disease worsers or you withclraw from the sftrdy treahnent but uot from study follow-up. the study staff rvill coutact yotiapproximately every 12 weeks after you last visit to check on yotu healih stahrs (for a period of up to one year). If'they are not able to reach you, they may use a public iufonuation sogrce-(like corurty records) to obtain infonnation about your survival status only, which will be reported as part of the data fot the study'
\ilhet sre the risks and/or discomforts I might experience if I take part in this study?  
you nrny have side effects finm the drugs or procedu'es used in this shrdy, aud they will vary from persou to person. Stady doctors *iU ."rlt tly watch everyonetaking part irr.]he study for
"oy
,id" effects. However, tLe study doctors aud the study funders do not know all the side ef.iects tlat may happen, and unknowu side effeets that could occllr. The study doctors may give y"" *-*i"i". 6 h"b lessen the side effects. Is some cases! side efects can be serious, long iasting. a1d/or **y ouv., go away. There also is a mre risk of death. You should tatk to yotu' shrdytoctor aboui a,y side effects that you lrave while taki,g pad iu the study.  
Ifyou experteuce aoy severe side effeet, you sbould:
o Seek prufessional uredical help irunediately r Call yotu sfirdy doetor
. If necessaryr go to the trearest emergeocy room Potentirl Risks Relsted to BioPsY
The possible risk associateA witir iemoval of a piece of your cancer (a biopsy) depeuds ou the p"rt
-"f rfr" body wlrere the biopsy will be perfioiued. VoI ry.y experience P{u fi'oru the bropsy iit", und yor, *ry have bnrising, ,or"o"r, Lr scarring at thebiopsy site' Raryly, a pltieut who has had a biopsymay experience iiiection and/or iuternal bleeding and dependiug o-o th" location of the biopsy, .punctruJ t*g" and/or "collapse.d lung" (an abnormal collection of air or gas in the
,f,;;ffi;.i*rtu* tfrrf*ig from the cheit) may occru" Uncommonly. cornplicatious from Uiopsi*, "*L fife threate;iug. As with any interventioual procedure, other potentially seriotts coip[cations &om bleeding Ju org* damage rnay oceu'. These might require additional srugical interveution.  
Possible Side Effects of Varlilumeb (CDX-7127')
To date, varlilumab bas been administered to approxirnately l]O patieot yth larious typgs 9rf cancers, aad most siJe effects have been mild-to-moderate in intensity- safety data is available from 343 patients who were administered varliluurab aloue and the remaining who received varlih:nrab in combination with aaother agent(s). Side effects atlribrrted to varlilumab have included:
Corurnon (Out of 100 people who receive varlilumab, 20 or uore people may have):
o Fatigue {27W
r Rash Q4'/r)
couunon, sorue may be serious (out of 100 people who receive varlilwnab, at least l0 but less than 20 people maYbave):
r Nausea (13o/o)
o Itchilg {L6W
o Diarrhea (117o)
Less common, some may be serious (out of 100 people who receive varlilunab, at least 5 but less than 10 peoPle ruaY have):
o infirsiou reaction with syruptoms including chills, nausea, rash, hot flashes (8%)
o decreased aPPetite (7%) r vomiting (7olo)
o headache (7%)
r fever(6Yo)
A decrease in the lymphocyte corur! a t)'pe of wfuite blood cell, Iras comruonly bee* observed following administratiol oivarlilumaU al}O has ttot beeu associated with synptoux' Varlilumab has beeu-giveu in combination with other drugs that activate the iruflnure system called checLpoiit ithi!1161s, speeifically Opdivo (nilolumab), Teceutriq (atezolianruab), and Yervoy
(ipilimu,mb). Immrure:related side effects are expected withcheckpoint inhibitors and have bee' observed amogg the 202 patients who have received varlihunab in cornbination with these dnrgs. Serious dnrg ielated inuruure-related side effects requiring hospitalization, such as inflarnrnation of tlre digestive kact (colitis), inflammation of the liver (lrepatitis), afld . :_
inflarn*ration of the t,ig lpo"rooonitis) have rarely occured rvhen varlilumab has been given ia courbinatiou r,vith checlpoint inhibitort. On* patient who dev-eloped pneruuoy]tryEg-treated with varlihulab aud uivolrmtab died from this side effect' However' these side effects has not been greater than would be expected for the checkpoint inhibitors alone.  
Additional rare events requiring hospitalizatiog or othetwise considered sedous:
e bronchospasm o low salt (sodium) in blood o inflamtuation of the kidneY
Additional side effects thought possible:
In laboratory tests, varlilumab has demonstratedthe capacity to activate iuurure cells that are capable of deshoyiug tuuror cells. However, varlihrma6 may also activate immune cells aud canse darlage to no;ral tissue. Yadilumab induced activation of lonnal irnmune eells may cau$e symptoms euring or shortly nftsl fisishing the varlihunab infusion. Signs and sy[rptoms of such an infirsio' r"u"tiin *oy incluCe low blooi presstue, fever, shortness of breath' vomiting' abdomiual pain, rash and ofher synptoms that may bernild to moderate or that cotrld be severe aud lead to life tfrre"ieoing .o*pli"otiotls such as renal failtue, ure[tal status chalrges and even death. Because vartiltunab- is a protein, it is also possible that you could have an allergic reaction to varliltunab with similar sigps at}d sytuptoms as just deseribed' Therefore' yorr will be ruouitored 1o ilrs slinic for 60 ruinutes uft*' 'u""iti*g the 6nrg (&e us*al time frarne in which these types of exfeme reactions may develop). as well-as tluougilrout the strdy.period' Other types of immtrue u"tl""ti"g antibodies h*v" L*e* tested i, people and have had side effects ranglng from mild to life tlu'eateuiug' Based ol} shrdies of other autibodies that activate the imrurure systeflr in different ways, the following side effects &ight also be possible:
r hair loss,loss ofpigpentation (eolor) ia the skin (vitiligo)
r severe inttammaiiJn of the gastrointlstinal tract (including severe diarrhea' passage of .  
blood, abdomilal pain, damage to the lining of the intestine, perforatiol of-the intestine)'
Tlese *""1*;;yi" ,.rioo, ir tife tlueatening, and may require additiosal tueatmeuts sueh as treatnent with corticosteroids, blood transftisions, intravenous artificial nuh'ition.  
aod hospitalization. In some caBesr sigmoidoscopy, cololoseopiy (minimally invasive tests where yotp doetor inserts " *"of* in yotu rechtm to look inside your colon or part of it) or srugery ruaY be required.  
e Change* io oumb*, of tlle variotrs fypes of cells rn-the blood, such as ueutrophils (which fight Lfectioo) "nd platelets (which urake blood clot)'
. Changes ur frractioniflg iu the organs of theendocrine system: pitritary inflammatiot/faihue (iausirg *"igt t loss, fatigue, weakness. deprcssiou, loss of enerpry, rausea, rorrltlos ios of opp.tite,;d confrrsion; usually treatable brrt can rarely be fatal), orref or under-activatiou ofthe thyraid (hyp-othgroidism or hyperthyroidism)'
adreual insufliciency (if not reateJ, a*enat io*"ifi"iuo"y may result in severe abdomiflal pains, diarrhea, ysmi{ing, muscle weakness aud fatigue, depressio& extremely low blood pressure, weipfit lorr, kiifu*y fail*re, changes in mood aud personality,.*d shock) ald deereased fiurction of the testes or ovaries-(causing loss of sexual frmction/drive, muscle loss, sleep disturbauce, ruoodlmeutal disoriers, lois of bone Dlass, loss of hair, infertility ald other sYmPtoms)
r Iuflaurmatio[ of the eye (causiDg visual disturbances or pailr)
Based on experience with ofher irnmuue activating antibodies, it is expected  
  
above were to occru, they would likely be quickly controlled with appropriate therapy. Flowever, it is possible that side effects could potential rapidly yorseu and become life-tlueateuins-and-even cause death. AlyJelay in treaiing these side "ff""tt uray prolong their duration' and make theru more diffictrlt to teat. You should always report 8ny uow symptoms during your reguler study visits, ard immetli*tely contact the study rloctor if you develop any worrisome symptoms including the following:
Diarrhea:
o An igcrease by 2 or more bowel nroveruents a day above yotu nornral paffem, especially if they wake you up at niglrt or fhe ruge to move your bowels coilles on suddenly. Even if you o= not feelinipartidrhrly unvell" DO NOT DELAY IN CONTACTING THE
STUDY PTrySICIAN OR NURSE.  
r ANY blood in the bowel moveurentso eveo if there is no diamhea-
. Al.Iy marked change in bowel habits, either new constipation or dian{rea-
Abdominal (Stomach) pain or teudemess:
r Even if there is no dianhea, and particularly if the pain is associated rvith a fever or requires the use of pain med.ications. Note: narcotic pain relievers used for abdorninal
(stomach) pain ean suppress diarrhea or symptours of other adverse events - please check with the stldy pfuysici* o. nu'se before using for abdominal (stomacb) pain-
For patielts with tnmors positive for CD27 (formd in some cancers of the blood)' it is possible that varlilgrnab could r"pidly kill the tnmor cells and cause some&ing called tunor lysis syndr.ome. This is urlikely to happen wiCIr varlihuuab but if it were to occul it could cause
"Log", i1laboratory tests withoitt any associated symptous, or in $evele cases, daruage to the kidney or other organs.  
As varlil'mab acts on CD2T, it is possible that varlihxnab could cause leukemia or llnrphoma maligpraacies that expr-ess CD27 to grow and therefore worsen tlre clioieal situatio[- Ano&er t;r;Sihfy is tlgt varliiumab *uy rfu norual cD27 positive irarmure cells that could result in an increased risk for developing infections. It is unlikely that these two risks will achrally occur because they have uot been obserrred in testing with varlihunab, ilcluding in animal shrdies' If you were to require prolonged treahneut with medications that stlppre$s iuununity. such as steroids, to nauage * serio.rr-iide effect associated with varlilunab audlor atezoliauuab, your body,s ability to fignt off cerlain infections (i.e., opportunistic infections) may be lowered' These infections may require tueahuent with antibiotic oiantifrrngal medicatious and may be fatal' Possible Sitle Effecfs of Lung Radiation comnron, Some ruay be serious (5% of people who receive radiation, nray lrave):
I Swelling and rednes, 6nning, thickeniog, fiun]bness, or peeliug of the skin in the area of radiation r Difliculty andlor pain with swallowing r Hair loss is the treatment area' rnay be pennaaent o Shortuess of breath e Cough with or without iucreased phlegm productioa e Tiredness o Pain in chest wall Less Common, Some maybe serious (5% or less of people wbo receive may have):
r Inflammation oitt . luug that ruay cause difficulf treathing aud can be life'ftreateuing r Narrowing of the throat which may cause vomiting, diffrculty swallowing r Scarring in the luug r Luug collapse r Fluid arotmd lu*gs r Bleeding &orn the hmgs which ilray cause coughing up blood r Fever r Narrowing of the esophagus Possible Side Eff$cts of Atozolizumsb (]I{PDL3280A)
Commoo, Some may be serious (20olo of people who receive atezolianrnab may have):
. Tireduess r Lrfection Less Courmotr, some uray be serious (At least 4olo but less than 2fr0/o af 100 people who receive atezolizwnab may have) :
o Anemia which uray require blood transfruioo o Diarrhea, [ausea! vouriti,g o Diffrsultyswallowing o Fever r Flu-like synptome including body aches r Iufirsion reactior, where ygn may feeldizq or faint, flushed, get a rash, have a fever' feel short of breath at the time of receiving your infiuion flf) or just aftet, or pain at the site of infusion o Loss of appetite o Pain in bsck r Cougb, shortness of breath, stufff nose o Itching, aure, rash r Low tevel ofsalt in the bloodthat may causc you to feel tired, coafused, have a headache' muscle cramps andlor feel sick to yotu stomach Atezolizumab (MpDL3280A) may cause yoru irmnune system to attack nonnal orgalrs and eause side effects in many parts of ihe Ulay. mese problems ruay incltrde but are 1161 linrited to:
o Hormoue glaad problems (especially the thyrnid, pirylt ry and .lfrenat g{ands, ard pancreas).-Sigr a"a ry*pto** *ui loUa": headaches that will not go away or unusual
-headaches,
"it "*" tiredaess or changes in mood orbehavior, deereased sex drive; weight loss or weight gain; excessive thirst or uriue; dizziness or faiuting r Pain in belly r Pain or swelliag of the joints o Rash that develip, oo *kio, nails, scalp and inside of mouth or vagina that may be paiufrrl Uncorumoni some ruay be serious (less than 4olo of people who receive atezolizumab may have):
o Bruising, bleeding Atezolizumab (MpDL3zgoA) may cause your imnnure system to attack nonual orgao$ and cause side effects in many parts of ihe uoay. m.r. problerus may include but are ilot lirnited to:
r Heart probierns including swelling and heart failur:e. Syrnptorns and signs-of hearl problems may include: short&ess of breath, swelling of the ankles aod body.  
o A couditiou with high blood sugar which leads to tiredness, &'equeut tuiuatiou or excessive thirst o Iuflamnration of the eye so yotl rnay have eye reduess, bkured visioo, sensitivity to lig{rt, lrave eye pain, see floaters or have headaches o Intestinal problems (colitis) that can rarely lead to tears or holes in your intestine' Sipps and syr4ptous oi"oiitir may inctude: dianhea or increase in borvel movements, blood in yo* .toolr or dalk" tarry, sticky stools, severe betly pai[ or tenderuess-o Liver problelrs (hepatitis) which ea$ cause liver failure. Sr5rs and synptorns of hepatitis uray include: yellowiflg of your skin or the whites of your eyes, sevele nausea or vomiting; drowsiness; pain ix the right upper belly' 1 gwslling of tbe brain (meuiugitislencephatitis), which may causel headache' confusion, sleepiness, seizures, and stiff neck o problem of the muscle, includilg swellirrg" whieh caa cause muscle pain and severe n-ruscle weakness sometirues with dark ruine o h-obleur of the refves that cal cause paralysis, Signs and symptoms may include:
nruubuess, tingling of haads and feet; weakuess of the arms, [egs.  
r Kidney prcble.lns,-iu"lgdiag neplu'itis and kidney failue requiring dialysis' Sigus of kidney problerns ioay i""t**, -d""r"".. in the auromtt of urine, blood in yoru tuine' ankle swelling.  
r Lrurgprublems (paeumonitis and pletu'al effirsion). Synrptoms rnay ilclude: ilew or worsening couglh, chest pain, shortness of breath' o Severe inflanrmatiol of ihe skin so you rmy have peeling of the skin, itchiness andlor skin redress. The skin inflarlmation (i.e. pieling, itching. aad redrHss) could also be widespread throughout your body. More severe skiu reactions may iuvolve the iuside of yogr mouth, the siufaceof your eye and gu"ilol areas, and/or may cause the top layer of you skiu to peel frour all or"r yo* body which can csuse sevele infection o Inflarnrnatiol of the paucreas (a gtand in yoru'abdorneo that coutrols sugar levels) so you may have severe upper abdomirral pain that may urove to yotu"back, feel sick to yout stomach, and vomiting that gets worse whel you eaf r A coudition tlat *"y L*k" you feel weak aad tired and might have drooping of the eyelids, blurred or double vision, difficulty swallowing, slurred speech, weakuess in your artrs and legs. or difficulty breathiug o The formation of small clusters of imruune cells (called grauulomas) in parts of your body such as yotu lfquph nodes' eyes' skil, or ltrugs Ysrlilumal, combined with Atezolizumab varliluuab combined with atezolizumabEs beefl studied in auother clinical trial. A total 0f l8 patients with advanced caneer received the cornbination therapy. Tlre lost- frry:nt heafnreut relafed side effects were fatigue t3gl|rri.,,itchhg Q8'/o),aneuda (l7Yo), diarrhea {l7o/o) and nausea
(l74.Ho1ever, there also may be new side uff""tt of the combination that are not yet known that may occtu. you sSogld teli your doctor or ourse right away about any possible side effects that you experience rvith this combiriation heahnent-
REPRODUCTIYE RISKS
Both males and females will be i&hded in this study. If you are pre$IBnl, you_cao$ot prrti.ip-t* in this r11l;;. V"*-fr""fi tot becorue pt*gtr*iotfath-er a baby while participating in irri, *tiay because th*'dn gs in this study cau b" a-suo*iated with utknown risls that could affect you or au tmborn babY.  
Alt sgbjects asd their spouses or partters must use an effective birth coutrol method' Some
"*oropL,
of birth "orrt ol are the iollowiug: have had a prigr history of surgically-induced sterility (i.e., tubes tied, vasectorny), avoiding aay activity that could cause you to become
;r6;i(",; sexual;ot*r"o*u"), or..sing biib clntrol pills, I[ID, condom, or do.ble-barrier
"oo:t
*""piion diaphragpr with spermiciAat letty, tramclermal (hrougb yoty skin) or injectable contlaceptives.  
Whether you are a man or worll{ur, you must praclice birth control dtutrg the study and for at leasr tluee mooths after you receive the last d;se of the study drug. Before eutering the study, you and the shrdy doctor must agtee on the birth coatrol ureilhod you will-use dw}S the entire rtray A corurselor and more inirmation about prwentiug pfegna'lcy will be made available to you if you lrave auY questions.
Clinical trial: NCT04081688
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Sre The Possible Risks Of Sample Banking?|Economic Risls Of Harm

l. The most conuuou risks related to rlrawing blood fiom your arrl are brief pain aad possibly a bruise.  
Z- Th"r" is a risk that someoae could get access to the persoratr information in your medical reeords or other infonnation researchers have stored abotrt you.  
3. In some cases, this information could be used to mske it harder for you to get or keep a job or insurance. There ale laws aga.inst the misuse of genetic infonnatiou, but they rnay not giwe firll protection. There can also be a risk in hrowing genetic inforxratioq.  
New health infonnation about inherited haits that might affect you or you blood relatives could be forurd dtring a study. The researchers believe the chance these things will lrappen is very srnall but caorot prourise that they will not oectu.

Sin"" ro** genetic variatious can help to predict the futtue health problems of you aud yoru relatives, tfiis information might be of interest to health providers, Iife insuraoce companies. and others. Therefore, yoru geuetic information potentially could be trsed in ways that eould cause you or yoru farnily ecoronric dishBss.  
There are state and federal laws that pCItect against genetic discrimination:
There is a federal law call the Genetic Inforuration Nondiscrimination Act (GINA)- In general, this law makes it illegal for healtb insuance companies, group health plans, and most employers to discriurinate agaiust youbased or yotr genetic inforuratiou. This law generally will protect you in the following ways: (l) health instuance companies and group health plans may Dof iequest yoru.geuetic infonuatiou that we get fi'om this research; (?) health insurance compa[ies
*d go.rp neafttr plans may not use yotu genetic infonnatiou whel ruaking decisions regarding your eligibilfy or premiums; and (3) employers with 15 or more ernployees may not use your genetic infonuatiog that we get from this research when making a decision to hire, promote, or lrru yo,, or when seffing the Gnus of your employment. However, it does not protect you against discrimination by cornpauies that sell life instuaoce, disability ittslu'a$ce, or long-terrr care insruance.  
IIow will informrtion *bout me in the hiorcpository be kept private?  
your privacy is very important to tlre researchers aud they will make every effort to protect it.  
Here are just a few olthe steps they will take:
1) -Whm tlre biorepository serds your sample(s) to the researchets, it will not send information identiffiug you (such as yollr rame, address. phone number or other personal identifyiug infonuatiot). The biorepository will ideutiff the samples by a unique code only.  
2) Yogr study doctir will keep the list that links the rurique code to yoru name- The list wi1 be kept sep*rate fiour your sample and health iuformation. Any staff with access to the list must agree to keep yoru ideutity confidential.  
3) Researehers who receive your sample(s) and inf,onnation will not know who you are' TIrcy must also ag;ree that they will not try to find out wtro yotl are.  
4) The biorepository-staff will not give iaformation that identifies you to anyone. trnless required by law.  
5) If researchers publish results, they will uot use yoru Dame or other persoual information.
Clinical trial: NCT04081688
Section: Procedures
Subsections: While On Study Treafneut:|How Will Tissue Samples Be Collected ?|What Is Involvei} In Sample Banking?

Druing the treatrnent@od, you will need the following exarninations, tests, and procedtues described below. Some of these exams, tests, and pro""d*"t are part of your regulal rnedical care' you will have the followiug dose ou Day I of every 2l day cycle:
o you will lrc askeJto report aay symptour.s and health problems yoil have and auy uew medicatious You have started.  
r You will have a complete physical examination your physic'*. ?t physiciau's assistant, includigg measrrement of your vital signs (breathi[g rate, blood presfl[e.  
temperatffe, and hearl rate), height' ard weight' r Evaluation of yoru ability to carry out daily activities' r You will have blood tests:
. About 2 ieaspoons for routine testing, such as, a complete blood count. kidney, and liver firnction tests-
. About I teaspoon for thyroid frurctiou tests every 3 weeks
. Approximatety + teaspotn for research (collected only on day 1 of cycle 1 aud 2)
ftruror Assessments: You *iil hur" a CT scan of the chest and/or abdomen every 9 weeks while receiviflg shrdy treahtrent to check horv your caocel is responding to the treatrnent' Tumor Biopsy: You will be asked to have aII additiorral huuor biopsy after Cycle 2 of treahnent. The reseat'ch biopsy is done in a similar way to biopsies done for diagnosis' Thi* ,urnpl. is required beeause the resea[ch otr the sarnple is an iruportant parf of the
*ar. Tlis tissue will be tested for certain protein.s and b-iomarkers (indicators of normal biological or disease processes) that may be involved in immune activatiou or to untlerstand the naftue of your disease. The ftnuor sa processed and stored at the Iaboratory iests are new and tmder deve-lopmeut. Any remaurmg slrdes alter I
conrpleted will be saved for frrtrue research if you aglee. The cost testiug is of tlre biopsy will be covered by the studY.  
Yotu doctor will stop shrdy treatmeut if arry of the following occur':
o yotn hrmor ppo*riog*. or you clevelop new hrurors (disease progression) o You develop rur*cceptable side effects o you becorne pregxlant or are tmwilling to use appropriate birth coiltrol techniques o The study doctoidetepnines that it is uot in your best interest to coutinue the sfudy heahnent r New infonnation becomes avarlqblq r The shrcly is stoppeil uy tu*f Review Board GRB) or FDA'
r You choose to stop sfudY heafouent After vou have completed study treatrnett:
After all study heaturett has stopped. your doctor will ask you to rehu:r to the clinic for an end of heatmeut visit, whicll *itt U" ,ppi*i**tely 30 days after yotu last dose of,shrdy dnrg' The following asses$nents will be done at these visits:
o you will be asked to repor,t auy synptour.s and health problems you have and 8ny new medicatioffi You have started.  
r you rvill have a complete physieal examination, with your physiciau or physician's assistant, including rrr""**.roJnt of your vital sigrs ftreathiug rate, blood pres$ue' temperature' aud lreart rate), heigfit, and weight-o Evaluation of yotn'abitrity to carry out daily activities'

Only the leftover tunor tissue that rras collected during the fwo required truno: biopsies as part of this research shrdy would be stored and rxed for fi.rtrue researclt. Blood will also be collected ouday I of cycle I audcycle 3.  
you can still be in the stndy whether or not you allow leftover samples to be used for fufme research.  
l. My leftover blood ancl tissue may be stored in a Biobank for rue iu ftltrue unspecified cancerlehted research. Medical iufotruatiou related to the sample rnay also be collected-  
I Yes (subject's initials)  
  
ENo (strbject's initials)
OPTIONAL SAMPLE BANKING TOR T'UTURE RESEARCH STUDTES:
A fresh sample of hxnor tissue (biopsy) will be collected prior to starting treatrnent in trial aud a secosd r.ropt" will be collected after cycle 2. Researchers will use the tissue samples to shrdy biomardrers. giomarkers are tesfs that idelti$, predict, or clmracterize yoru'cancer. Some examples of caucer biomar.kers are CEA tesffor colon cancer, PSA test for prostate cancer and HER-2 or BRCA l/2 tests for lrreast cancer.  
r P*rt of the tissue sample will be rxed to meastue the amourt of PD-LI in the hrmor. r part of the tissue sarrple urill be used to measure how mueh, and where your tunor expresses irnmune biomarkers These types of samples are called correlative saanples. These laboratory tests are uelv and under development. There is a risk of possible loss of confidentiality' Your p:ivacY 1s very irnPortatt and the researchers will make every efforl to protect it. Shrdy staff will identi$ your correlative sample results by a uniqrre code. Resealchers rvill keep the list that links the code to your nilae separate from you sample and health iufonnation.

If you agree to take parl, here is what will happen next:
l. yoru.study doctor will send " *"*piu fiorn the tissue that was c,ollected at the time of each biopsy to &e biorepository.  
2- Yotu'sfudy doctor urill send blood samples collected on day I of cycle I and eycle 3 to the biorepository.  
3. The biorepository rvill store yotu' saruple artd some related h"ultl, ilfot nati*, rnuy be stored in the biorepository, aloug with saurples and infor:nation &om otlrer people who take part in this saruple collection. The biorepository will store the saruples rurtil they are used trp by the study researchers.  
4. Neither the biorepository or the study researchers wlm use the samples will notiff you or your study doctor wheu research is conducted or give reports or other i*formation about aly research that is doue trsiug yoru banked samples'
Clinical trial: NCT04081688
Section: Purpose of Research
Subsections: Consent To Take Part In A Rtrsearch Study

TITLE OF STUDY: A Phase I Trial of Atezolizumab and Varlilumab in Combication with Radiation irr Patients with Metastatic Nou-small cell hurg cancer (NSCLC)
Principal fnvestigator:
fan infonned consent process for a research  
  
study and it will provide infonnation that wili help you decide whether you walt to take part i' this study. It is yourchoice to take parl or not. The pupose of the research is to: test the lood a*d Uua .ff""tr of the shrdy dnrgcalled varliltunab when giverr in cor[bination with iurmunotherapy with atezoliaunab and radiatiou for the treahnent of lung caneer' If you take part in the research, yotr will be asked to receive the strdy drrrg, varlihuuab in co[rbinatio:r iith atezoliztulab evety three weeks- You will also receive radiatiol to one of you hrmor lesions. Yogr time in the study will be as long as yotu hrmor is responding to the shrdy treatmeut (up to orre year). Possible hanus orlb*deo* of taking parl in the snrdy ruay be side effects fiom the study tr.eatruent and additional visits for tlrc research testing. Possible benefits of takiag part may be an improvement in your health as lvell as {rollection of new informatiou about G study dnrg as a triahnent for hurg caucer. Your alteroative to takiug part in the research is oot to take part in it.  
The itrformation in this consent form will provide more details abo tt the research study ard what will be asked of yotr if you choose to take part in it. If you have auy questions now or druing the study, if you choose toiake part, you should feel &'ee to ask them and shotrld expect to be given aoswers you completely underctanrl. After all of yoru'questions hal'e beeu answered and yort
,,vish to take part in the-research shtdy. you will be asked to sigu tltis consent fonn- You are uot eivhg up ani of yoru legal rights by apeeiug to take part in tlis research or by signing this conseut form.  
\ilho is conducting this research study?  
E-is the Principal Investigator of this research shrdy' ffiIffiGiir"=irotsibitity for the corrduct o@ there are often otlter individuals who are parl of the research teaur.  
^A Principal Investigator The Principal iuvestigator or another member of the study tearn will also be asked to sigu this informed consent. You will be given a copy of the sigued conseut form to keep' Why is this study being tlone?  
Your immune sysferu sends out special cells called T cells to fight iufections  
  
throughout yotu body. Some cancu cells can hide from these T cetls-by t*Tg cootrol of a path;y calied pD-I/PD-LI. This lets the caocer cells avoid ao attack from T cells' Inrmrmotherapy drugs such as Atezoliztrmab (Tecentriq) block the PD-l/FD-L} pathway' By blocking pD-l or pi-l-t, these dnrgs restore tlre body's irnmune response against cancer cells and allow the immrme system to recoqnize and kill cancer c.ells. PD-LI targeting dnrgs such as atezolizumab are Dow FLod and DnrgAdminislration (FDA) approved for the heatment of advanced or stage fV non-smatt cell lung cancer OISCLC).  
Althouglr immuuotherapy drugs such as atezolizumab lead to improved survival.and are better toleratet. they work *iy i" sJme patients. Research is now focused on ways to increase the nuuber of patients who respond to these drugs. These research apptoaches includetesting combination of pD-llpD-lt drugs with other treatureuts such as chemotherapy and radiation.  
Varlilumab is a new irnmrurotheiapy that also sllppresses pathways (CD27) used by cancer eells to escape attack by immuue system.  
This study is beiug doue to test the good andbad effects of the studl drug calledvarlilumab when given in combinatiol with atezolizrunab (anti-PD-Ll).and radiation. Giving you this medicitiol in combination with irnmrrnotherapy with atezolinrmab and radiation may increase the amourt of time your disease is not active or does not spread to another part of yotu body. The use of varliltunab iu this shrdy is iuvestigational. "Investigational" Dteans that this uredication has not yet been approved bythe FDA to heat the type of cancel you have' Y9y voltrutary participation in thii-r*s"urch study may help to find out whether this drug is effective at lengthering the tinre until yotu cance{ starts to gpow.  
\ilho may take part in this study and rvho may not?  
you rnaytake part in this study ii you are l8 years of age or p'eater with advanced nou-surall cell lung cancer. Additionally, you rnay take part in this study ifi r You have received therapy witlr chemotherapy as well as PD-I/PD-Ll talgeted immunotherapy previously to treat your lung cancer r you agree to have * biopsy before starting treahnent ou the trial and a secord biopsy after cycle 2 r Youhave a hrmor lesion in the hurg that can be treated with radiatiou o You have read and sipned this lnformed Consent Form You tnay not take part in this shrdy if r You are uuable to keep youl doctor's aplroi:rtments r You are pregn*nt or breast feeding o You have an active infection o You have au autoimmuue disease or are on hig$-dose steroids T5e study doctor aud/or research tearn will also ask you other questions about yotu uredical history ia order to make slue yotl qualiff to be in this shrdy.  
Why have I been erked tc take part in this study?  
yori are being asked to take part in this sfudy because yorr have uon-small cell lung cancer
(NSCLC). Yiu have alreadybeen treatedwith a PD-I/PD-LI targeting irumunotherapy such as pembroliarmab, nivolunab, durvalumab or atezoliztrnrab. Your disease is now not r.esporrd to the inrmunotherapy treatment. People who are not in a sttrdy with chemotherapy {rugs such as paclitaxel, doceturel, pemetlexed or gemcitabiue' How long will the study take and how mlny subjects will take part?  
iily treiment withvarlilgmab will confiuue for as long a$ your'ftrmog is respondigg (up to one y**'! *a you are not experieucing sevefe side effects- At the end of one year of treatment' you may conti,ue to receiveih"r*py rJith atezolizuruab if yotu- caocel has not gotten worse' Affer yo.ih.o" stopped receiving treatment o,, thrdy, we rvill contimre to follow up with you for one
!ear. flr" utoa, a*gr;ili" given i* rurits oitime called cycles' O,e cycle equals 2l days (3 weeks).  
About 15 uatieuts will take part iu this shrdy and all patients wilt be eurolled at flre!  
-
What wiII I be asked to do if I take part in this study?  
Before yotr begin study treatmeut:
you will have some *I*r. t"*t* ""a procedtues to firrd out if you can take part in this study' Most of fhe exftrns) t"rts, *a procedures you will have are part of flre usual approach for your c{urcer. However, yourdoctoiwill do some exba testiug as part of the study. The testing that you will need to have if you take part in this study is discussed below. If some of these have been doue rcceutly they may not need to be repeated' this rvill be up to the study doctor' o Yotu age and race/ethnicity will be recorded' o you will be asked about yotu rnedical history artd any rnedications you are crurently taking, both prescription and ovel the counter' o You will bave a eomplete physieal evarnination, wi,th your physiciq gt physician's assistant, incltrding measurement of your vital signs (breathing rate' blood plessure?  
temperaftre, audheart rate), height, aad weight' e Evaluation of your ability to cany out daily activities' o The followiugblood saruples will be collected within 28 days of registratiot:
. AbojZ teaspooni (10 mL) for routine testing, such as, a coruplete blood coturt, kidney a11d liver firnctiou tests to ersure that it is safe to administer any of the drugs hcluded in this studY
r About I teaspoon (5 nrl-) for thyroid flrnction testing r A ruine sauple wilt be collectedv'rithiu 28 days of registation' r If you o" * *rro**who could become preguant (even if you had yow hrbes tied), yotu dottor will perform a blood or tuine pfeEpellcy test. If you are pregrant, you caonot particiPate in this study.  
. Imaging tests typically performed for cancer patients, inctuding inraging of chest, abdomen andbrain. Scans may include:
. Computed tomoggaphy 1-Cf;, a scan that uses x-rays to look at one part of your body. It may be ioue *itl, o, without contrast. Contrast means that dye is injected intoyour o"io to increase the differences between nor-nral and abnonnal tissue'
. Magnetic resonauce iruaging (MRI), imaging that tues a stlong maEretic field to look at one Part ofYour bodY'
r Biopsy of tumor tissue: You will need to b*ve a fi'esh hrmor biopsy- This sample is
,=qol"A because the research ou the sample is an inrpofiant part of the study The re*ear"1rbiopsyisdorreinasimilar.,*yCIbiopsiesaredoa-efo,.dhffWl will be tested for certain proteins and biomarkers that may be related the study drug. The test may also help to Ydtl*tt3{l$lll hunor sample will be processed aud stored at the These laboratory tests are tew and wrder developrnent' renmmmE! s te$ti$g i* compl"ted will be saved for funue research if you aglee. The cost of the biopsy will be covered bY the studY.  
If you do uot meet the eligibility s, you lallot take part in this study' The stu'rly doctor will infonu you of other options that are available to you.  
STUDY TREATMENT
If the tests, exarls, procedrues show that you can be in the shrdy, you will be registered' All study participants will receive varlilurnab, radiatiou therapy and atezolizrunab.  
o Varlilumab: you will receive varlilumab every 2t days on day I of each cyele. Varliluruab will be givea inkavenously (IV) throu*h a veia over 90 minutes" e Atezoliz.mab: you will receive atezolizumab every 2l days on day 2 of each cycle-Atezolizumab will be given iutravenously (Iv) through a vein over 30 minutes' o Radiation Therapy: You witl receive radiation therapy for 5 days betleel the first aild secoud cycles. Tf,e radiation will be to one of the luag tumor le-sions- Each heatuent may take up to 15-30 minutes depending on the technique used. Before you begin radiation therapy. you will have irnaging of the chest iu order to design yoruradiatios tre*tment' Doetors will rue ilformation gathered from these scans to plan the best wty to deliver radiation to Your fumor.
Clinical trial: NCT04081688
Section: Voluntary Participation
Subsections: Agreement To Participate 1. Subject Consent:|2. Signature Of Investigator/Individual Obtaining Consent:|Afrrssmeiim To Parti Cipete 1. $Uble*T Cipusert:|2, Slgnature Of Tnvmtlgator./Indil Ttlu*L Obtaxnlng Constut:|For Non-English.Speaking Subjects : Signature Of Reader/Tr*Nslator If The Subject Does Not Read English Weli:

I have read this entire colseut font, or it has beel re*d to nle, and I believe that I uuderstand what las been discussed. All of my questions about this furur and fhis shrdy have been auswered. I agree to take part in this study.  
Subject Name:.  
Subject Sigrrafm'e: Date:

To the best of ny ability, I lmve explaiuerl and discussed all the impofiant details about the shrdy including all of the infotnation contained io this conseut fonn' Investigator/Person Obtaining Consent (printed name):
Sigruattue Date:

I hate r€ad thi$ ettim eou$rgt form. or it har b*en rqd to me, aud tr helisve tlrat I underrtand urbat has ksr discussed. Atl of my questions about this fonn md Sris str*dy h*vt becn answsed. I ngrxe ts take pm1ful thi* shrdy' Subject Nanre:
$ubject Signatrrre: Date:

To &e best of rny abiliff. I have exptni*ed and discussed all the impo$ant details abont the study includiug allof tlre infonuatiou coutaiued in this corsent fsxnt.  
InvestigafortP erson Obt ain ing C on surt (priuted u atue ) :
Siprahrre: Date:

The person who has sigoed the shorl for:n, ., does not read
_ (naure of the English well. You read English well and are fluent ia knlrage), a laupruage that ihe subject (his/her: parent(s)/legat grrardian) rurderstands well. You rurderstand the conteut of this consent fonu and you have translated for the subject (his/het parent(s)/legal guardian) the entire content of this form. To the best of yoru knowledge, the subject (hisiher parent(s)/legal gtrardian) rurderstands the coutent of this fom and has had an opportunity to ask questions regarding the consent fonu and the study, and these questions have been answered (his/her parent(s)/legal gualdian).  
Reader/Tratslator Narue :
ReaderlTnanslator Siguatrue:
Date:
WihessName:
Clinical trial: NCT04081688
Section: Withdrawal from Study
Subsections: Tilhat Wiii Heppen If I Do Not Wish To Take Part In The Sturly Or If I Later Decide Not To Stay In The Study? It Is Your Choice Whether To Take Pafi In The Research. You May Choose To Take Part, Not To Take Part L You May Cha[Ge Your Mind Aild Withdraw Froru The Sfudy At Aoy Time-

If you do ilot wanl to enter the study or decide to stop taking part, your'lelatiouship with the stridy staffwill uot change, and yoti may do so without penalty and without loss of benefits to whichyou are otherwise eutitled.  
You may also withdtaw yotu coDqqul&ltlE use of data already collected about you' but you ruust do this in writing r;- (address provided oa page l).  
of Hurnan Research Services at
;ffi.TIEA;-"*, beca*se there may not be any by the Food arrd Drug Adrninistratios the to however, to coutinue to report anything that relates to the sa{bty of these drrrgs' At any time, the shrdy doctor can take you or$ of this study if it would not be in your best interest to stay iu it. your stuiy 6octor can stop keatment eveu if you are rvilling to stay in the study' If yorr decide to withdraw frorn the sfird fbr any reason, you may be asked to rehmt for at least one additional visit for safety reasors.  
Also, you should understaud that the Sponsor, in consultatios with the study doctor, can withiiaw you from the skrdy at auy time if you d9 uot folloy the insfirrctions relate'd to the rt iay, if VLu ueed a different treatnreat, or if you have a study-related injury'
\ilho can I call if I have questions?  
If you have questious abotit taking part in this sfudy or if you feel you rrray have suffered a research related injury, you car call the shrdy doctor:
r can call the IRB
The next few paragraphs tell you abotrt how investigators wailf to use and share identifiable health infonuation frim vourjmedical record in this research. Your infonnation witl oulybe used asdescribedhereor"@law.Ifyousigpthisconsenttbrrn.yotragreetolet the i*vestigators use your identifiatrle healthinfor:nation in the research aud share it with others as described below. Ask questious if there is sourething you do not understand'  
  
-
what is the purposc of the rcscarch etrd how will my information bp used?  
you are being invited to take pafi in this research study, which is described at the begirn{g -of this form. Th-e pgrpose of colGcting ard using your health infonuation for this study is to help investigators anslry€t the questious that are being asked in the rpsealch.  
Whst informrtion about me will be used?  
o All iafornoatioa in your medical record r Hoqpital discharge surutraxiefl o Radiology records or images (MRI, CT, PET scans) r Medical history or foeatment c Physicalexaminations r Medications r Consultations r Laboratory/diagrrostic tests or imaging r Pathology and operative reports, specimen{s) or slide(s) r Records related to blood and other tissue samples
Who may use, share or receive my iuformrtion?  
The research team 1uay use or share yotu ilfonuation eollected or created for this study with the ilstitutions:  
  
  
Those persons or orgauizations that receive your information may uot be required by Federal privacy laws to protect it aud may share your information with others without yotu pennission, if pennitted by the laws governing them.  
Will I be able to review my re$csr€h recortl while the research is ongoing?  
No, We are not able to share infonnation iu the research records with you until the study is over' To ask for this infor:nation. please contact the Principal lnvestigator, the persot in charge of this research study.  
Do I have to give my permission?  
No. You do not haveto permit use of yotu iuforrnation. But, if you do not give permission, you carmot take part in this study (Saying no does uot stop you tom getting medical care or other bese{its you are eligible for outside of this study.)
If I say yes ro1rr, can I ch*nge my misd and take *way my permission later?  
yus. you may changle yo.rr *iud and uot allow the continued use of yotu inforrnatiou (and to stop taking pad iD tU. *toay) at any tiure. If you take away per:rrission, yotu infomr3tiou will so lopger beirsed or shared iri iUe shrdy. but we will not be able to take back inforuration ak'"ady been used or shared with others. If you say yes now but chauge yoru voru infonnation in the research, you urust lvrite to the researcher and tell him or her of yoru' How long will mY Peruission last?  
There is no set date rrrhen your permissior will end. Your health bformation may be studied for many years.