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For timeframe of recording adverse events, please refer to section 6.1 . All serious adverse events recorded from the time of first investigational product administration must be reported to the sponsor with the exception of any listed in section 8.4 .
untitled h1
8.3 reporting of serious adverse

Any AE that meets protocol-defined serious criteria or meets the definition of Adverse Event of Special Interest that require expedited reporting must be submitted immediately (within 24 hours of awareness) to OSRO Safety using the CCR SAE report form. Any exceptions to the expedited reporting requirements are found in section 8.4.  
All SAE reporting must include the elements described in section 8.2 .  
SAE reports will be submitted to the Center for Cancer Research (CCR)
at:
OSROSafety@mail.nih.gov. CCR SAE report form and instructions can be found at:
https://ccrod.cancer.gov/confluence/display/CCRCRO/Forms+and+Instructions Following the assessment of the SAE by OSRO, other supporting documentation of the event may be requested by the OSRO Safety and should be provided as soon as possible.
untitled h1
w waiver of expedited reporting

As death/hospitalization due to disease progression are part of the study objectives (OS, ORR) and captured as an endpoint in this study, they will not be reported in expedited manner to the sponsor. However, if there is evidence suggesting a causal relationship between the study drug and the event, report the event in an expedited manner according to section 8.3 .
untitled h1
s afety r eporting c

will be All required pregnancy     reports/follow-up     to     OSRO
submitted to:
OSROSafety@mail.nih.gov __.  
Forms and instructions can be found here:
https://ccrod.cancer.gov/confluence/display/CCRCRO/Forms+and+Instructions
untitled h1
maternal exposure 8.6.1

If a patient becomes pregnant while still under study requirement to use contraception, the study treatment should be discontinued immediately if participant still on study therapy, and the pregnancy must be reported to the Sponsor no later than 24 hours of when the Investigator becomes aware of it. The Investigator should notify the Sponsor no later than 24 hours of when the outcome of the Pregnancy become known, Pregnancy itself is not regarded as an SAE. However, congenital abnormalities or birth defects and spontaneous miscarriages that meet serious criteria (section 8.1.2 ) should be reported as SAEs.  
The outcome of all pregnancies occurring from the date of the first dose of study therapy until 4 months after the last dose should be followed up and documented.
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8.6.2 paternal exposure

Male patients should refrain from fathering a child or donating sperm during the study and for 4 months after the last dose of study therapy.  
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non-parametric test, such as the Wilcoxon rank sum test. The analyses will be done for all patients and separately for the patients treated at the MTD or highest dose level.  
.  
To evaluate changes in the tumor microenvironment as well as plasma cytokine release following treatment with intratumorally administered LMB-100 and ipilimumab. Any analyses done for this endpoint will be done using descriptive methods only.  
.  
To evaluate the utility of serum mesothelin and megakaryocyte potentiating factor (MPF)
as biomarkers of tumor response, the levels will be compared between responders and nonresponders using an appropriate exact two-group non-parametric test, such as the Wilcoxon rank sum test. The analyses will be done for all patients and separately for the patients treated at the MTD or highest dose level.  
Any statistical tests performed for evaluation of exploratory objectives will be done without formal adjustment for multiple comparisons, but in the context of the number of tests performed.
untitled h1
human subjects protections 11 11.1

LMB-100 is a mesothelin-targeted cFP and has shown preclinical dose-dependent activity in monotherapy and/or combination in xenografts representing MSLN-positive indications (NSCLC,
mesothelioma, triple negative breast cancer, gastric cancer, pancreas, ovarian, potentially other tumor indications). LMB-100 has shown synergy in laboratory models with inhibitors of CTLA-
4. Ipilimumab is an anti-CTLA-4 inhibitor. The rationale to evaluate LMB-100 with ipilimumab in advanced/metastatic mesothelioma is to determine the effect of the addition of ipilimumab to intratumoral LMB-100 therapy. All patients meeting the criteria listed in section 2.1 are eligible for enrollment.
untitled h1
1.2 participation of children

There are no dosing or adverse event data are currently available on the use of LMB-100 with ipilimumab in patients <18 years of age; therefore, children are excluded from this study.
untitled h1
11.3 participation of subjects unable

Adults unable to provide consent are excluded from enrolling in the protocol. However, it is possible that subjects enrolled in the protocol may permanently lose the capacity to consent for themselves during the course of this study.  For subjects that lose the ability to consent due to tumor progression, they will be taken off treatment but will have the opportunity to remain on study in long term follow-up for collection of outcomes for overall survival. If the reason for incapacity is due to a reason other than definitive disease progression and they are felt to be responding to the treatment under study in the opinion of the investigator, they will have the opportunity to continue this therapy.  
All subjects will be offered the opportunity to fill in their wishes for research and care, and assign a substitute decision maker on the "NIH Advance Directive for Health Care and Medical Research Participation" form so that another person can make decisions about their medical care in the event that they become incapacitated or cognitively impaired during the course of the study. Please see section for the consent procedure. Note: The PI or AI will contact the NIH Ability to Consent Assessment Team (ACAT) for evaluation as needed for the following: an independent assessment
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members and/or other advisors, and to ask questions of any designated study investigator. A signed informed consent document will be obtained prior to entry onto the study.  
The initial consent process as well as re-consent, when required, may take place in person or remotely (e.g., via telephone or other NIH approved remote platforms used in compliance with local policy, including HRPP policy 303 ) per discretion of the designated study investigator and with the agreement of the participant/consent designee(s). Whether in person or remote, the privacy of the subject will be maintained. Consenting investigators (and participant/consent designee, when in person) will be located in a private area (e.g., clinic consult room). When consent is conducted remotely, the participant/consent designee will be informed of the private nture of the discussion and will be encouraged to relocate to a more private setting if needed. Consent will be documented with required signatures on the physical document (which includes the printout of an electronic document sent to participant) or as described below, with a manual
(non-electronic) signature on the electronic document.  When required, witness signature will be obtained similarly as described for the investigator and participant.  
Manual (non-electronic) signature on electronic document:
When a manual signature on an electronic document is used for the documentation of consent at the NIH Clinical Center, this study will use the following to obtain the required signatures:
Adobe platform (which is not 21 CFR Part 11 compliant); or,
.  
iMedConsent platform (which is 21 CFR Part 11 compliant)
During the consent process, participants and investigators will view individual copies of the approved consent document on screens at their respective locations (if remote consent); the same screen may be used when in the same location, but is not required. Both the investigator and the participant will sign the document using a finger, stylus or mouse.  
Note: Refer to the CCR SOP PM-2, Obtaining and Documenting the Informed Consent Process for additional information (e.g., verification of participant identity when obtaining consent remotely)
found at:
https://ccrod.cancer.gov/confluence/pages/viewpage.action?pageId=73203825 .
untitled h1
1.5.1 consent process for adults

For participants addressed in section 11.3 , an LAR will be identified consistent with Policy 403 and informed consent obtained from the LAR, as described in section 11.5 .
untitled h1
12 regulatory and operational considerations

This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable cause. Written notification, documenting the reason for study suspension or termination, will be provided by the suspending or terminating party to IND sponsor and regulatory authorities. If the study is prematurely terminated or suspended, the Principal Investigator (PI) will promptly inform study participants, the Institutional Review Board (IRB), and sponsor and will provide the reason(s) for the termination or suspension. Study participants will be contacted, as applicable, and be informed of changes to study visit schedule.  
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| E(0/28 68)((&0       |              | |C    |    |
| J%&'( 42/. { @20*/2@ |              | |  |    |
| J20*/2@ ‰/'-0*&0'                      | z+-@20*/(/' |     | |C    |
| hxqrm' [kƒts Swtqq                      |             |    |    |  
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|---------------------------------------------------------------------|--------------------------------|-------|----|
| $>?@(A'&                                                            | B 36                           |       |    |
| C-+'5A5C-.'&                                                        |                                |       |    |
| DEFGHIEIHJKL                                                        | M                              | NON       |    |
| DPQHREQSHEF PTTULHJK                                                |                                 | VOMW  |    |
| DPQHREQSHEF IEXGJKESP                                               | N                              | OM       |    |
| DPQHREQSHIHL                                                        | N                              |       |    |
| YHKUL IERZ[REQSHE                                                   | W                                | \O]V       |    |
| ^EQ EKS _E`[QHKIZ aHLJQSPQL                                         | ^bIPQKEF PEQ GEHK              | ]     | \O]    |
| ^KSJRQHKP aHLJQSPQL                                                 | c[GJIZ[QJHSHLX                 | ]     | \O]    |
| ^[P aHLJQSPQL                                                       | ^[P SHLJQSPQL d eIZPQf LGPRHT[ | ]     | \O]    |
| g`SJXHKEF SHLIPKLHJK                                                |                                 | ]OV]  |    |
| KEF GEHK                                                            | h                              | iOV       |    |
| gLRHIPL                                                             | ]                              | \O]       |    |
| jJKLIHGEIHJK                                                        | W                              | MO\N  |    |
| aHEQQZPE                                                            | W                              |       |    |
| aQ[ XJUIZ                                                           | ]                              | \O]       |    |
| a[LGPGLHE                                                           | M                              | NON       |    |
| kEULPE                                                              | h                                | NONh       |    |
| lGGPQ                                                               | mELIQJHKIPLIHKEF               |       |    |
| ZPXJQQZEmP                                                          | ]                              | \O]       |    |
| $%&'() *+,-. /0-&&                                                  |                                |       |    |
| nELIQJHKIPLIHKEF aHLJQSPQL                                          | oJXHIHKm                       | ]M    | ]]Oh    |
| jZHFFL                                                              | W                              | MO\N  |    |
| ^SPXE TERP                                                          | i                              | WOVW  |    |
| FHX`L                                                               | Nh                             | N]OMW |    |
| pEIHmUP                                                             | WM                             | MNOWW |    |
| pPqPQ                                                               | W                                | \O]V       |    |
| nPKPQEF                                                             | SHLJQSPQL                      | EKS   |    |
| ESXHKHLIQEIHJK LHIP RJKSHIHJKL  d eIZPQf LGPRHT[                    | ]                              | \O]       |    |
| nPKPQEFHrPS PSPXE                                                   | ]                              |       |    |
| sQQHIE`HFHI[                                                        | ]                              |       |    |
| _JREFHrPS PSPXE                                                     |                                 | ]iOiM |    |
| tEFEHLP                                                             | ]                              | \O]       |    |
| kJKdREQSHER RZPLI GEHK                                              | V                              | MOM       |    |
| nPKPQEF aHLJQSPQL EKS  gSXHKHLIQEIHJK YHIP  jJKSHIHJKL              | DEHK                           | ]\    | O\V    |
| sXXUKP Y[LIPX aHLJQSPQL                                             | gFFPQmHR QPERIHJK              | ]     | \O]    |
| sXXUKP L[LIPX SHLJQSPQL d  eIZPQf LGPRHT[                           | ]                              | \O]       |    |
| cPQGPL LHXGFPb QPERIHqEIHJK                                         | ]                              |       |    |
| sKTPRIHJKL EKS HKTPLIEIHJKL d  eIZPQf LGPRHT[                       | ]                              | \O]       |    |
| sKTPRIHJKL EKS sKTPLIEIHJKL                                         | _UKm HKTPRIHJK                 | ]     |    |  
| 1/2 /3))3. 4(+)5.303,%  /+5'(+5- 63+ 789(+&( :9(.'&  ;/4/7:< 4(+)   | = 36                       |          |       |    |
|---------------------------------------------------------------------|----------------------------|----------|-------|----|
| $>?@(A'&                                                            | B 36                       |          |       |    |
| C-+'5A5C-.'&                                                        |                            |          |       |    |
| JKLMNOP                                                             | QRSTRKSKU                  | EKV DEFF | G     | HIG    |
| QNRWXVMNEF YRZ[FSWE\SRKT                                            | JK]MTSRK NXFE\XV NXEW\SRK  | G^       | GGI_` |    |
| aFEKSKX                                                             | EZSKR\NEKT]XNETX           |          |       |    |
| SKWNXETXV                                                           | G                            | _b       |       |    |
| aFcEFSKX                                                            | [dRT[dE\ETX                |          |       |    |
| SKWNXETXV                                                           | GG                         | Ie          |       |    |
| aT[EN\E\X  EZSKR\NEKT]XNETX  SKWNXETXV                              | ^e                         | eI`          |       |    |
| YENVSEW \NR[RKSK J SKWNXETXV                                        | b                          | ^IH          |       |    |
| YQf SKWNXETXV                                                       | b                          |          |       |    |
| YNXE\SKSKX SKWNXETXV                                                |                             | _gIgG    |       |    |
| hLXW\SRK ]NEW\SRK VXWNXETXV                                         | G                          | HIG          |       |    |
| JKiXT\SUE\SRKT j k\dXNP T[XWS]O                                     | G                          |          |       |    |
| lOZ[dRWO\X WRMK\ VXWNXETXV                                          | b^                         | ^Ibb          |       |    |
| mXM\NR[dSF WRMK\ VXWNXETXV                                          | `                          | eI_g     |       |    |
| QFE\XFX\ WRMK\ VXWNXETXV                                            | G^                         | GGI_`    |       |    |
| ndONRSV T\SZMFE\SKU dRNZRKX  SKWNXETXV                              |                             | _I^_     |       |    |
| oNSKX RM\[M\ VXWNXETXV                                              | G                          | HIG          |       |    |
| pXSUd\ UESK                                                         | ^_                         | Ie          |       |    |
| SUd\ FRTT                                                           |                             | _I^_     |       |    |
| $%&'() *+,-. /0-&&                                                  |                            |          |       |    |
| JKiXT\SUE\SRKT                                                      | pdS\X qFRRV WXFF VXWNXETXV | _G       | GgI`^ |    |
| aKRNXrSE                                                            | _                            | GIbb          |       |    |
| sXdOVNE\SRK                                                         | b                          | ^IH          |       |    |
| tO[XNWEFWXZSE                                                       | G                          | HIG          |       |    |
| tO[XNUFOWXZSE                                                       | G                          |          |       |    |
| tO[XNKE\NXZSE                                                       | _                          | GIgG     |       |    |
| tO[XNMNSWX tO[REFqMZSKXZSE                                          | ``                         | e`I^          |       |    |
| tO[RWEFWXZSE                                                        | e                          | bIgb     |       |    |
| tO[RcEFXZSE                                                         |                             | gI^b     |       |    |
| tO[RZEUKXTXZSE                                                      | _                          | GIgG     |       |    |
| tO[RKE\NXZSE                                                        | ^`                         | `Ib_          |       |    |
| uX\EqRFSTZ EKV mM\NS\SRK  sSTRNVXNT                                 | tO[R[dRT[dE\XZSE           | b        | ^IH       |    |
| aN\dNEFUSE                                                          | g                          | ^I^          |       |    |
| uMTWMFRTcXFX\EF EKV  YRKKXW\SiX nSTTMX sSTRNVXNT                    | vEWc [ESK                  | ^        | I_       |    |
| DFEKc [ESK                                                          |                             | _I^_     |       |    |
| wXKXNEFSxXV ZMTWFX yXEcKXTT                                         |                             | _        |       |    |
| uOEFUSE                                                             |                             | _gIgG    |       |    |  
| 1/2 /3))3. 4(+)5.303,%  /+5'(+5- 63+ 789(+&( :9(.'&  ;/4/7:< 4(+)   | = 36                        |       |      |
|---------------------------------------------------------------------|-----------------------------|-------|------|
| $>?@(A'&                                                            | B 36                        |       |      |
| C-+'5A5C-.'&                                                        |                             |       |      |
| DEFG HIJK                                                           | L                           | MNL       |      |
| OIJK JK EPQRESJQT                                                   | U                           | LNVL  |      |
| WXIYZ[ST[\T]J]                                                      | L                           | MNL       |      |
| DE[H\I]S]                                                           | ^EKJ_K`                     |       |      |
| aI\J_KIKQ IKZ bK]HEFJcJEZ  deKF\ fT]Q] gKZ O[\TH]h ijS[R HIJK       | k                           | UNU       |      |
| f[Kcj]J[K                                                           | U                           | LNVL  |      |
| lJmmJKE]]                                                           | LU                          | nNV       |      |
| lT]_Ej]JI                                                           | L                           | MNL       |      |
| oEIZIFXE                                                            |                              | VNp       |      |
| qEQXIR_T                                                            | L                           | MNL       |      |
| OERJHXERI\ S[Q[R KEjR[HIQXT                                         | L                           |       |      |
| OERJHXERI\                                                          | ]EK][RT                     |       |      |
| KEjR[HIQXT                                                          |                              | VNp       |      |
| ORE]TKF[HE                                                          | L                           | MNL       |      |
| r[SK[\EKFE                                                          | L                           |       |      |
| rTKF[HE                                                             | L                           |       |      |
| $%&'() *+,-. /0-&&                                                  |                             |       |      |
| DERs[j] rT]QES lJ][RZER                                             | iRES[R                      | L     | MNL      |
| O]TFXJIQRJF lJ][RZER]                                               | eK][SKJI                    | U     | LNVL |
| gFjQE GJZKET JKtjRT                                                 | p                           | NMk       |      |
| WEKI\ IKZ bRJKIRT lJ][RZER]                                         | OR[QEJKjRJI                 | n     | uNUV |
| WEHR[ZjFQJsE rT]QES IKZ  ^REI]Q lJ][RZER] OE\sJF HIJK               | L                           | MNL       |      |
| g\\ER_JF RXJKJQJ]                                                   | L                           |       |      |
| f[j_X                                                               | U                           | LNVL  |      |
| lT]HKEI                                                             | Uu                          | ULNuu |      |
| oTH[PJI                                                             | p                           | NMk       |      |
| O\EjRI\ Eccj]J[K                                                    | u                           | pNVp  |      |
| O\EjRJQJF HIJK                                                      | p                           | NMk       |      |
| OKEjS[KJQJ]                                                         | L                           | MNL       |      |
| OR[ZjFQJsE F[j_X                                                    | L                           |       |      |
| Oj\S[KIRT EZESI                                                     | L                           |       |      |
| WE]HJRIQ[RT cIJ\jRE                                                 | L                           |       |      |
| r[RE QXR[IQ                                                         | U                           | LNVL  |      |
| WE]HJRIQ[RT` iX[RIFJF IKZ  aEZJI]QJKI\ lJ][RZER]                    | bHHER RE]HJRIQ[RT JKcEFQJ[K | L     | MNL      |
| g\[HEFJI                                                            | LM                          | NMV       |      |
| lRT ]GJK                                                            | L                           | MNL       |      |
| OERJ[RYJQI\ EZESI                                                   | U                           | LNVL  |      |
| ORjRJQj]                                                            | k                           | UNU       |      |
| rGJK IKZ rjYFjQIKE[j]  iJ]]jE lJ][RZER]                             | WI]X SIFj\[vHIHj\IR         |        | kNUk |  
| 1/2 /3))3. 4(+)5.303,%  /+5'(+5- 63+ 789(+&( :9(.'&  ;/4/7:< 4(+)   | = 36                 |       |    |
|---------------------------------------------------------------------|----------------------|-------|----|
| $>?@(A'&                                                            | B 36                 |       |    |
| C-+'5A5C-.'&                                                        |                      |       |    |
| DEFG HGI JKLMKNHGOPKJ NFJJKO  IFJPQIOQJ R SNTOQU JVOMFWX            | Y                    | Z[Y       |    |
| \HVF]]HQX ]OHE JXGIQP^O                                             | YY                   | [_       |    |
| `]KJTFGa                                                            | b                    | Y[cY  |    |
| dXVOQNOGJFPG                                                        | e                    | f[bf  |    |
| dXVPNOGJFPG                                                         | fe                   | b_[eb |    |
| gHJMK]HQ hFJPQIOQJ                                                  | iTQP^LPO^LP]FM OjOGN | Y     | Z[Y    |
| $%&'() *+,-. /0-&&                                                  |                      |       |    |  
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| CDEFG   | HGIJDKLMKNOI                                                                                                                                                                                                                                                                              |
|---------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| P       | QNDRES EJMKTKMUV WXSSU EJMKTGY EZSG MN JEDDU NO ESS LDG[FKIGEIG  LGD\NDREOJG ]KM^NXM DGIMDKJMKNOV `URLMNRIY ZXM ERZXSEMNDUV aGIMDKJMGF KO L^UIKJESSU IMDGOXNXI EJMKTKMUY  ZXM ERZXSEMNDU EOF EZSG MN JEDDU NXM ]NDb N\ E SKc^M ND IGFGOMEDU OEMXDG  dGVcVY SKc^M ^NXIG]NDbY N\\KJG ]NDbeV |
| _       | gO ZGF hiPj N\ M^G MKRGV kRZXSEMNDU EOF JELEZSG N\ ESS IGS\[JEDGY ZXM  XOEZSG MN JEDDU NXM EOU ]NDb EJMKTKMKGIV lL EOF EZNXM RNDG M^EO iPj  N\ ]EbKOc ^NXDIV                                                                                                                              |
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| o       | _PPj ZGFDKFFGOV nNRLSGMGSU FKIEZSGFV nEOONM JEDDU NO EOU IGS\[JEDGV  pNMESSU JNO\KOGF MN ZGF ND J^EKDV                                                                                                                                                                                    |
| i       | HGEFV                                                                                                                                                                                                                                                                                     |  
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