Clinical trial NCT03848845: Study Evaluating Safety, Tolerability and Clinical Activity of GSK2857916 in Combination With Pembrolizumab in Subjects With Relapsed/Refractory Multiple Myeloma (RRMM)
Official title: A Phase I/II Single Arm Open-Label Study to Explore Safety and Clinical Activity of GSK2857916 Administered in Combination With Pembrolizumab in Subjects With Relapsed/Refractory Multiple Myeloma (DREAMM 4)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Multiple Myeloma
Keywords: GSK2857916, Pembrolizumab, Multiple Myeloma, RP2D
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2019-02-21
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Subjects will receive GSK2857916 at escalating doses along with pembrolizumab on Day 1 of each 21-day Cycle to establish RP2D during the Part 1 of the study. Subjects will receive GSK2857916 at RP2D along with pembrolizumab on Day 1 of each 21-day Cycle in Part 2 of the study.
Primary purpose: TREATMENT

Brief summary: This is a phase I/II, single arm, open label, two-part study that will assess safety, tolerability and clinical activity of GSK2857916 given in combination with a programmed cell death-1 (PD-1) inhibitor pembrolizumab in subjects with RRMM. This study will enroll adult subjects with RRMM, who have undergone stem cell transplant or who are considered transplant ineligible. Part 1 is a dose escalation phase to evaluate the safety and tolerability of escalating doses of GSK2857916 in combination with 200 milligrams (mg) pembrolizumab to establish the recommended phase 2 dose (RP2D). The following dose levels of GSK2857916 are planned to be studied: 2.5 milligrams per kilograms (mg/kg) (dose level \[DL\] 1) and 3.4 mg/kg (DL2). Part 2 is a dose expansion cohort. Once the RP2D has been identified, an expansion cohort will open for enrolment to confirm the safety profile and to evaluate the clinical activity of the combination. Up to 40 evaluable subjects will be enrolled in this two-part study (up to 12 in Part 1, and 28 in Part 2).


Eligibility criteria: Inclusion criteria:

* Provide signed written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
* Male or female, 18 years or older (at the time consent is obtained).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Subjects must: have histologically or cytologically confirmed diagnosis of Multiple myeloma (MM), as defined by IMWG, 2014 and has undergone stem cell transplant or is considered transplant ineligible, and has been treated with at least 3 prior lines of prior anti-myeloma treatments including an immunomodulatory imide drug (IMiD) (eg. lenalidomide or pomalidomide), a proteasome inhibitor (eg. bortezomib, ixazomib or carfilzomib) and an anti-CD38 antibody alone or in combination. Line of therapy are defined by consensus panel of the International Myeloma Workshop, Has measurable disease defined as one the following: a) Serum M-protein \>=0.5 grams per deciliter (g/dL) (\>=5 grams per liter \[g/L\]). b) Urine M-protein ≥200 mg/24h. c) Serum Free light chain (FLC) assay: Involved FLC level ≥10 milligrams per deciliter (mg/dL) (≥100 milligrams per liter \[mg/L\]) and an abnormal serum free light chain ratio (\<0.26 or \>1.65).
* Subjects with a history of autologous stem cell transplant are eligible for study participation provided the following eligibility criteria are met: a) transplant was \> 100 days prior to study enrolment. b) no active infection(s). c) subject meets the remainder of the eligibility criteria.
* Adequate organ system functions as defined by the laboratory assessments.
* All prior treatment-related toxicities (defined by National Cancer Institute-Common Toxicity Criteria for Adverse Events \[NCI-CTCAE\], version 4.03, 2010) must be \<= Grade 1 at the time of enrolment except for alopecia and Grade 2 neuropathy.
* A female subject is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of childbearing potential (WOCBP) OR is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), preferably with low user dependency, during the intervention period and for at least 120 days after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. A WOCBP must have a negative highly sensitive serum pregnancy test (as required by local regulations) within 72 hours before the first dose of study intervention. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
* Male subjects are eligible to participate if they agree to the following during the intervention period and for at least 140 days after the last dose of study intervention. Male subjects should refrain from donating sperm, plus, either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR Must agree to use a male condom and female partner to use an additional highly effective contraceptive method with a failure rate of \<1% per year when having sexual intercourse with a woman of childbearing potential who is not currently pregnant.

Exclusion criteria:

A subject will NOT be eligible for inclusion in this study if any of the following criteria apply:

* Systemic anti-myeloma therapy or an investigational drug \<=14 days or five half-lives, whichever is shorter, preceding the first dose of study drug
* Plasmapheresis within 7 days prior to the first dose of study drug
* Prior treatment with a monoclonal antibody within 30 days of receiving the first dose of study drugs
* Has received prior therapy with an anti-PD-1, anti-Programmed cell death Ligand 1 (PD-L1), or anti-Programmed cell death Ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated antigen 4 \[CTLA-4\], OX 40, CD137) and was discontinued from that treatment due to a Grade 3 or higher immune related adverse event (irAE)
* Current corneal epithelial disease except mild punctate keratopathy
* Any major surgery within the last four weeks prior to the first dose of study therapy
* Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect subject's safety). Subjects with isolated proteinuria resulting from MM are eligible, provided they fulfil criteria as per adequate organ system function mentioned under inclusion criteria.
* Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities) that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures.
* Has received prior radiotherapy within 2 weeks of start of study therapy. Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (\<=2 weeks of radiotherapy) to non-central nervous system (CNS) disease.
* History of (non-infectious) pneumonitis that required steroids, or current pneumonitis
* Current active liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.
* Malignancies other than disease under study are excluded, except for any other malignancy from which the subject has been disease-free for more than 2 years and, in the opinion of the principal investigators and GSK Medical Monitor, will not affect the evaluation of the effects of this clinical trial treatment on the currently targeted malignancy (RRMM). Subjects with curatively treated non-melanoma skin cancer are allowed.
* Has known active CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study therapy
* Evidence of cardiovascular risk including any of the following: a) corrected for heart rate by Fridericia's formula (QTcF) interval ≥470 msecs. b) Evidence of current clinically significant uncontrolled arrhythmias; i. including clinically significant ECG abnormalities including 2nd degree (Type II) or 3rd degree atrioventricular (AV) block. c) History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within six months of Screening. d) Class III or IV heart failure as defined by the New York Heart Association functional classification system. e) Uncontrolled hypertension. f) Presence of cardiac pacemaker (or defibrillator) with a predominantly ventricular paced rhythm, limiting ECG/QTcF analysis. g) Abnormal cardiac valve morphology (\>=Grade 2) documented by echocardiogram (subjects with grade 1 abnormalities \[i.e., mild regurgitation/stenosis\] can be entered on study). Subjects with moderate valvular thickening should not be entered on study.
* Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to GSK2857916 or pembrolizumab, or any of the components of the study treatment.
* Pregnant or lactating female.
* Known active infection requiring antibiotic, antiviral, or antifungal treatment.
* Known Human Immunodeficiency Virus (HIV) infection.
* Presence of hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) at screening or within 3 months prior to first dose of study treatment
* Positive hepatitis C antibody test result or positive hepatitis C Ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study treatment.
* Has received a live-virus vaccination within 30 days of planned start of study therapy.
* Active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other chronic form of immunosuppressive therapy within 7 days prior the first dose of study therapy.
* Has known psychiatric or substance abuse disorder that would interfere with the subject's ability to cooperate with the requirements of the study.
* Has had an allogenic tissue/solid organ transplant

Primary outcomes:
measure: Part 1 - Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to approximately 31 months
measure: Part 1 - Number of Participants With Dose Limiting Toxicities (DLTs)
timeFrame: Up to 21 days
measure: Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
timeFrame: Baseline (Day 1) and up to approximately 31 months
measure: Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
timeFrame: Baseline (Day 1) and up to approximately 31 months
measure: Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters
timeFrame: Baseline (Day 1) and up to approximately 31 months
measure: Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters
timeFrame: Baseline (Day 1) and up to 31 months
measure: Part 1 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results
timeFrame: Baseline (Day 1) and up to approximately 31 months
measure: Part 1 - Changes From Baseline in Urine Potential of Hydrogen (pH)
timeFrame: Baseline (Day 1) and Week 46
measure: Part 1 - Changes From Baseline in Urine Specific Gravity
timeFrame: Baseline (Day 1) and Week 46
measure: Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
timeFrame: Baseline (Day 1) and up to approximately 31 months
measure: Part 1 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature
timeFrame: Baseline (Day 1) and up to approximately 31 months
measure: Part 2 - Percentage of Participants With Overall Response Rate (ORR)
timeFrame: Up to approximately 31 months
Secondary outcomes:
measure: Part 1 - Percentage of Participants With Overall Response Rate (ORR)
timeFrame: Up to approximately 178 weeks
measure: Part 2 - Number of Participants With AEs and SAEs
timeFrame: Up to approximately 178 weeks
measure: Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
timeFrame: Baseline (Day 1) and up to approximately 178 weeks
measure: Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
timeFrame: Baseline (Day 1) and up to approximately 178 weeks
measure: Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters
timeFrame: Baseline (Day 1) and up to approximately 178 weeks
measure: Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters
timeFrame: Baseline (Day 1) and up to approximately 178 weeks
measure: Part 2 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results
timeFrame: Baseline (Day 1) and up to approximately 178 weeks
measure: Part 2 - Changes From Baseline in Urine Specific Gravity
timeFrame: Baseline (Day 1) and until end of treatment (up to 178 weeks)
measure: Part 2 - Changes From Baseline in Urine pH
timeFrame: Baseline (Day 1) and until end of treatment (up to 178 weeks)
measure: Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: DBP and SBP
timeFrame: Baseline (Day 1) and up to approximately 178 weeks
measure: Part 2 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature
timeFrame: Baseline (Day 1) and up to approximately 178 weeks
measure: Part 2 - Number of Participants With Maximum Worst-case Change From Baseline in Best Corrected Visual Acuity Test (BCVA) Scores
timeFrame: Baseline (Day 1) and up to approximately 178 weeks
measure: Part 2 - Time Taken for the Onset of First Occurrence of Worsening in BCVA Score
timeFrame: Up to approximately 178 weeks
measure: Part 2 - Outcome of First Occurrence of Worsening Eye in BCVA Score
timeFrame: Up to approximately 178 weeks
measure: Part 2 - Duration of First Occurrence of Worsening in BCVA Score
timeFrame: Up to approximately 178 weeks
measure: Part 2 - Number of Participants According to the Number of Definite Events of Worsening of Vision
timeFrame: Up to approximately 178 weeks
measure: Part 2 - Number of Participants With Resolution of Post Treatment Exposure Worsening in BCVA Score
timeFrame: Up to approximately 178 weeks
measure: Part 2 - Duration of Resolution Post-treatment Exposure of Worsening in BCVA Score
timeFrame: Up to approximately 178 weeks
measure: Part 2 - Number of Participants With Post-baseline Decline in BCVA to Light Perception or no Light Perception
timeFrame: Baseline (Day 1) and up to approximately 178 weeks
measure: Part 2 - Number of Participants With Worst-case Shift From Baseline in Ophthalmological Epithelium Exam
timeFrame: Baseline (Day 1) and up to approximately 178 weeks
measure: Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations
timeFrame: Baseline (Day 1) and up to approximately 178 weeks
measure: Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings
timeFrame: Baseline (Day 1) and up to approximately 178 weeks
measure: Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations
timeFrame: Baseline (Day 1) and up to approximately 178 weeks
measure: Part 2 - Percentage of Participants With Clinical Benefit Rate
timeFrame: Up to approximately 178 weeks
measure: Part 2 - Duration of Response
timeFrame: Up to approximately 178 weeks
measure: Part 2 - Time to Response
timeFrame: Up to approximately 178 weeks
measure: Part 2 - Time to Best Response
timeFrame: Up to approximately 178 weeks
measure: Part 2 - Progression-free Survival
timeFrame: Up to approximately 178 weeks
measure: Part 2 - Time to Disease Progression
timeFrame: Up to approximately 178 weeks
measure: Part 2 - Overall Survival
timeFrame: Up to approximately 178 weeks
measure: Part 1 - Maximum Concentration (Cmax) for Belantamab Mafodotin After First Dose
timeFrame: Pre-dose, end of infusion (EOI), 2, 4, 9, and 24 h post-SOI (start of infusion) on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
measure: Part 2 - Cmax for Belantamab Mafodotin After First Dose
timeFrame: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
measure: Part 1 - End of Infusion Concentration (C-EOI) for Belantamab Mafodotin
timeFrame: EOI post belantamab mafodotin dose on Day 1 of each 21 day Cycle till Cycle 11
measure: Part 2 - C-EOI for Belantamab Mafodotin
timeFrame: EOI post belantamab mafodotin dose on Day 1 of each 21 day Cycle till Cycle 11
measure: Part 1 - Time of Cmax (Tmax) for Belantamab Mafodotin After First Dose
timeFrame: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
measure: Part 2 - Tmax for Belantamab Mafodotin After First Dose
timeFrame: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
measure: Part 1 - Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) for Belantamab Mafodotin
timeFrame: Pre-dose on Day 1 of each 21 day cycle from Cycle 1 until Cycle 13
measure: Part 2 - Ctrough for Belantamab Mafodotin
timeFrame: Pre-dose on Day 1 of each 21 day cycle from Cycle 1 until Cycle 13
measure: Part 1 - Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast) for Belantamab Mafodotin After First Dose
timeFrame: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
measure: Part 2 - Tlast for Belantamab Mafodotin After First Dose
timeFrame: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
measure: Part 1 - Area Under Plasma Concentration-time Curve (AUC) From Time 0 to End of the Dosing Interval [AUC (0-tau)] for Belantamab Mafodotin After First Dose
timeFrame: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
measure: Part 2 - AUC (0-tau) for Belantamab Mafodotin After First Dose
timeFrame: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
measure: Part 1 - Cmax for Total Monoclonal Antibody (mAb) After First Dose
timeFrame: Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
measure: Part 2 - Cmax for Total mAb After First Dose
timeFrame: Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
measure: Part 1 - C-EOI for Total mAb
timeFrame: EOI post belantamab mafodotin dose on Day 1 of Cycle 1, Cycle 2, Cycle 5, Cycle 8, and Cycle 11
measure: Part 2 - C-EOI for Total mAb
timeFrame: EOI post belantamab mafodotin dose on Day 1 of Cycle 1, Cycle 2, and Cycle 5
measure: Part 1 - Tmax for Total mAb After First Dose
timeFrame: Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
measure: Part 2 - Tmax for Total mAb After First Dose
timeFrame: Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
measure: Part 1 - Ctrough for Total mAb
timeFrame: Cycle 1, Cycle 4, Cycle 7, Cycle 10, and Cycle 13
measure: Part 2 - Ctrough for Total mAb
timeFrame: Cycle 1 and Cycle 4
measure: Part 1 - Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast) for Total mAb After First Dose
timeFrame: Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
measure: Part 2 - Tlast for Total mAb After First Dose
timeFrame: Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
measure: Part 1 - AUC (0-tau) for Total mAb After First Dose
timeFrame: Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
measure: Part 2 - AUC (0-tau) for Total mAb After First Dose
timeFrame: Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
measure: Part 1 - Cmax for Cysteine Maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) After First Dose
timeFrame: Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
measure: Part 2 - Cmax for Cys-mcMMAF After First Dose
timeFrame: Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
measure: Part 1 - C-EOI for Cys-mcMMAF After First Dose
timeFrame: EOI post belantamab mafodotin dose on Day 1 of Cycle 1
measure: Part 2 - C-EOI for Cys-mcMMAF After First Dose
timeFrame: EOI post belantamab mafodotin dose on Day 1 of Cycle 1
measure: Part 1 - Tmax for Cys-mcMMAF After First Dose
timeFrame: Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
measure: Part 2 - Tmax for Cys-mcMMAF After First Dose
timeFrame: Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
measure: Part 1 - Tlast for Cys-mcMMAF After First Dose
timeFrame: Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
measure: Part 2 - Tlast for Cys-mcMMAF After First Dose
timeFrame: Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
measure: Part 1 - AUC From Time 0 to 168 h After Dosing [AUC (0-168h)] for Cys-mcMMAF After First Dose
timeFrame: Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, and Cycle 1 Day 8
measure: Part 2 - AUC (0-168 h) for Cys-mcMMAF After First Dose
timeFrame: Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, and Cycle 1 Day 8
measure: Part 1 - Cmax for Pembrolizumab After First Dose
timeFrame: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
measure: Part 2 - Cmax for Pembrolizumab After First Dose
timeFrame: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
measure: Part 1 - Tmax for Pembrolizumab After First Dose
timeFrame: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
measure: Part 2 - Tmax for Pembrolizumab After First Dose
timeFrame: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
measure: Part 1 - AUC (0-tau) for Pembrolizumab After First Dose
timeFrame: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
measure: Part 2 - AUC (0-tau) for Pembrolizumab After First Dose
timeFrame: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
measure: Part 1 - Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin
timeFrame: Baseline (Day 1) and until end of treatment (up to 178 weeks)
measure: Part 2 - Number of Participants With Post-baseline Positive ADAs Against Belantamab Mafodotin
timeFrame: Baseline (Day 1) and until end of treatment (up to 178 weeks)
measure: Part 1 - Titers of ADAs Against Belantamab Mafodotin
timeFrame: Up to approximately 178 weeks
measure: Part 2 - Titers of ADAs Against Belantamab Mafodotin
timeFrame: Baseline (Day 1) and up to approximately 178 weeks
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Indianapolis
country: United States
facility: GSK Investigational Site
state: Indiana
city: Charlotte
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Madison
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Calgary
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Hannover
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Badalona
country: Spain
facility: GSK Investigational Site
city: Pozuelo De Alarcón/Madrid
country: Spain
facility: GSK Investigational Site
city: Salamanca
country: Spain
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: