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)
Overview
- Phase
- Phase 1
- Intervention
- belantamab mafodotin
- Conditions
- Multiple Myeloma
- Sponsor
- GlaxoSmithKline
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- Part 1 - Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Part 1: Dose escalation
Subjects will receive belantamab mafodotin at escalating doses of 2.5 milligrams per kilograms (mg/kg) and 3.4 mg/kg along with 200 mg pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day cycle to establish RP2D. There will be maximum of 35 cycles of combination treatment.
Intervention: belantamab mafodotin
Part 1: Dose escalation
Subjects will receive belantamab mafodotin at escalating doses of 2.5 milligrams per kilograms (mg/kg) and 3.4 mg/kg along with 200 mg pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day cycle to establish RP2D. There will be maximum of 35 cycles of combination treatment.
Intervention: Pembrolizumab
Part 2: Expansion cohort
Subjects will receive belantamab mafodotin at RP2D along with 200 mg pembrolizumab via IV infusion on Day 1 of each 21-day cycle. There will be maximum of 35 cycles of combination treatment.
Intervention: belantamab mafodotin
Part 2: Expansion cohort
Subjects will receive belantamab mafodotin at RP2D along with 200 mg pembrolizumab via IV infusion on Day 1 of each 21-day cycle. There will be maximum of 35 cycles of combination treatment.
Intervention: Pembrolizumab
Outcomes
Primary Outcomes
Part 1 - Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Up to approximately 31 months
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function.
Part 1 - Number of Participants With Dose Limiting Toxicities (DLTs)
Time Frame: Up to 21 days
DLT is an AE that is considered by the investigator to be clinically relevant and attributed to the study therapy during the 21 day DLT period and meets at least one of the DLT criteria: any Grade 4 and 3 non-hematologic toxicity, any Grade 3 or greater non-hematologic laboratory value, hematologic toxicity lasting \>=7 days, except Grade 4 thrombocytopenia of any duration or Grade 3 thrombocytopenia associated with clinically significant bleeding. Grade 3 or greater febrile neutropenia lasting \>48 hours (h) despite adequate treatment, Nephrotoxicity requiring dialysis, Liver toxicity, prolonged delay (\>14 days) in initiating Cycle 2 due to any treatment (pembrolizumab or GSK2857916) related toxicity, any treatment-related toxicity that causes discontinuation of treatment during Cycle 1, any other toxicity considered to be dose-limiting that occurs beyond 21 days and any other event which in the judgment of the investigator and GlaxoSmithKline Medical Monitor is considered to be a DLT.
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Time Frame: Baseline (Day 1) and up to approximately 31 months
Blood samples were collected for the analysis of following hematology parameters: hemoglobin, White blood cells (WBC) count, lymphocytes, neutrophils and platelet count. The laboratory parameters were graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Any worst-case post baseline increase in grade along with any increase to a maximum grade of 3 and a maximum grade of 4 are presented.
Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Time Frame: Baseline (Day 1) and up to approximately 31 months
Blood samples were collected for the analysis of following hematology parameters: basophils, eosinophils, mean corpuscular hemoglobin concentration (MCHC), mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), erythrocytes, hematocrit, monocytes, neutrophils and reticulocyte. The summaries of worst-case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented.
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters
Time Frame: Baseline (Day 1) and up to approximately 31 months
Blood samples were collected for the analysis of clinical chemistry parameters: glucose, alanine aminotransferase (ALT), albumin, alkaline phosphatase, aspartate aminotransferase (AST), blood bilirubin, calcium, creatine kinase (CPK), creatinine, gamma glutamyl transferase (GGT), magnesium, phosphate, potassium and sodium. Laboratory parameters were graded according to NCI-CTCAE version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Any worst case post baseline increase in grade along with any increase to a maximum grade of 3 and a maximum grade of 4 are presented.
Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters
Time Frame: Baseline (Day 1) and up to 31 months
Blood samples were collected for the analysis of following chemistry parameters: calcium, carbon dioxide, chloride, direct bilirubin, protein, thyrotropin (TSH), thyroxine (T4) and triiodothyronine (T3). The summaries of worst case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented.
Part 1 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results
Time Frame: Baseline (Day 1) and up to approximately 31 months
Urine samples were collected to assess urine glucose, protein, occult blood and ketones using dipstick method. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Result for urinalysis parameters were recorded as no change/decreased and any increase. Data for worst-case post baseline urinalysis results is presented.
Part 1 - Changes From Baseline in Urine Potential of Hydrogen (pH)
Time Frame: Baseline (Day 1) and Week 46
Urine samples were collected from participants to assess urine pH levels. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.
Part 1 - Changes From Baseline in Urine Specific Gravity
Time Frame: Baseline (Day 1) and Week 46
Urine samples were collected from participants to assess urine specific gravity. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Time Frame: Baseline (Day 1) and up to approximately 31 months
DBP and SBP were measured after resting for at least 5 minutes in a supine or semi-recumbent position. They were graded according to NCI-CTCAE version 4.03. For SBP: Grade 0 (\<=120 millimeter of mercury \[mmHg\]), Grade 1 (121-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (\>=160 mmHg). For DBP: Grade 0 (\<=80 mmHg), Grade 1 (81-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (\>=100 mmHg). Higher grade indicates greater severity. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst-case post baseline with any grade increase and a maximum post-baseline grade increase to Grade 3 from their baseline grade are presented.
Part 1 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature
Time Frame: Baseline (Day 1) and up to approximately 31 months
Vital signs (pulse rate and temperature) were measured after resting for at least 5 minutes in a supine or semi-recumbent position. The abnormal vital sign ranges were: For pulse rate (low \<60 beats per minute \[bpm\] and high \>100 bpm); For body temperature (\<=35 degrees Celsius or \>=38 degrees Celsius). Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst case change from baseline was presented as Baseline to low, Baseline to Normal or No change and Baseline to High.
Part 2 - Percentage of Participants With Overall Response Rate (ORR)
Time Frame: Up to approximately 31 months
ORR was defined as the percentage of participants with a confirmed partial response (PR) or better (i.e., PR, very good partial response \[VGPR\], complete response \[CR\] and stringent complete response \[sCR\]), according to the International Myeloma Working Group (IMWG) Response Criteria. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow; sCR=stringent complete response, CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component \<100 mg/24 h; PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 h.
Secondary Outcomes
- Part 1 - Percentage of Participants With Overall Response Rate (ORR)(Up to approximately 178 weeks)
- Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters(Baseline (Day 1) and up to approximately 178 weeks)
- Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters(Baseline (Day 1) and up to approximately 178 weeks)
- Part 2 - Number of Participants With AEs and SAEs(Up to approximately 178 weeks)
- Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters(Baseline (Day 1) and up to approximately 178 weeks)
- Part 2 - Changes From Baseline in Urine Specific Gravity(Baseline (Day 1) and until end of treatment (up to 178 weeks))
- Part 2 - Changes From Baseline in Urine pH(Baseline (Day 1) and until end of treatment (up to 178 weeks))
- Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: DBP and SBP(Baseline (Day 1) and up to approximately 178 weeks)
- Part 2 - Outcome of First Occurrence of Worsening Eye in BCVA Score(Up to approximately 178 weeks)
- Part 2 - Number of Participants With Worst-case Shift From Baseline in Ophthalmological Epithelium Exam(Baseline (Day 1) and up to approximately 178 weeks)
- Part 2 - Duration of Response(Up to approximately 178 weeks)
- Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters(Baseline (Day 1) and up to approximately 178 weeks)
- Part 2 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results(Baseline (Day 1) and up to approximately 178 weeks)
- Part 2 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature(Baseline (Day 1) and up to approximately 178 weeks)
- Part 2 - Number of Participants With Maximum Worst-case Change From Baseline in Best Corrected Visual Acuity Test (BCVA) Scores(Baseline (Day 1) and up to approximately 178 weeks)
- Part 2 - Time Taken for the Onset of First Occurrence of Worsening in BCVA Score(Up to approximately 178 weeks)
- Part 2 - Number of Participants According to the Number of Definite Events of Worsening of Vision(Up to approximately 178 weeks)
- Part 2 - Number of Participants With Resolution of Post Treatment Exposure Worsening in BCVA Score(Up to approximately 178 weeks)
- Part 2 - Duration of Resolution Post-treatment Exposure of Worsening in BCVA Score(Up to approximately 178 weeks)
- Part 2 - Number of Participants With Post-baseline Decline in BCVA to Light Perception or no Light Perception(Baseline (Day 1) and up to approximately 178 weeks)
- Part 2 - Progression-free Survival(Up to approximately 178 weeks)
- Part 2 - Time to Disease Progression(Up to approximately 178 weeks)
- Part 2 - Duration of First Occurrence of Worsening in BCVA Score(Up to approximately 178 weeks)
- Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations(Baseline (Day 1) and up to approximately 178 weeks)
- Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings(Baseline (Day 1) and up to approximately 178 weeks)
- Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations(Baseline (Day 1) and up to approximately 178 weeks)
- Part 2 - Percentage of Participants With Clinical Benefit Rate(Up to approximately 178 weeks)
- Part 2 - Time to Response(Up to approximately 178 weeks)
- Part 2 - Time to Best Response(Up to approximately 178 weeks)
- Part 2 - Cmax for Belantamab Mafodotin After First Dose(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)
- Part 1 - End of Infusion Concentration (C-EOI) for Belantamab Mafodotin(EOI post belantamab mafodotin dose on Day 1 of each 21 day Cycle till Cycle 11)
- Part 2 - C-EOI for Belantamab Mafodotin(EOI post belantamab mafodotin dose on Day 1 of each 21 day Cycle till Cycle 11)
- Part 1 - Time of Cmax (Tmax) for Belantamab Mafodotin After First Dose(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)
- Part 2 - Overall Survival(Up to approximately 178 weeks)
- Part 1 - Maximum Concentration (Cmax) for Belantamab Mafodotin After First Dose(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)
- Part 1 - Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) for Belantamab Mafodotin(Pre-dose on Day 1 of each 21 day cycle from Cycle 1 until Cycle 13)
- Part 2 - Tmax for Belantamab Mafodotin After First Dose(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)
- Part 2 - Tlast for Belantamab Mafodotin After First Dose(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)
- 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(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)
- Part 2 - AUC (0-tau) for Belantamab Mafodotin After First Dose(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)
- Part 2 - Cmax for Total mAb After First Dose(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)
- Part 2 - C-EOI for Total mAb(EOI post belantamab mafodotin dose on Day 1 of Cycle 1, Cycle 2, and Cycle 5)
- Part 2 - Ctrough for Belantamab Mafodotin(Pre-dose on Day 1 of each 21 day cycle from Cycle 1 until Cycle 13)
- Part 1 - Cmax for Total Monoclonal Antibody (mAb) After First Dose(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)
- Part 1 - Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast) for Belantamab Mafodotin After First Dose(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)
- Part 1 - C-EOI for Total mAb(EOI post belantamab mafodotin dose on Day 1 of Cycle 1, Cycle 2, Cycle 5, Cycle 8, and Cycle 11)
- Part 1 - Tmax for Total mAb After First Dose(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)
- Part 2 - Tmax for Total mAb After First Dose(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)
- Part 1 - Ctrough for Total mAb(Cycle 1, Cycle 4, Cycle 7, Cycle 10, and Cycle 13)
- Part 1 - Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast) for Total mAb After First Dose(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)
- Part 2 - Tlast for Total mAb After First Dose(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)
- Part 2 - AUC (0-tau) for Total mAb After First Dose(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)
- Part 2 - Ctrough for Total mAb(Cycle 1 and Cycle 4)
- Part 1 - AUC (0-tau) for Total mAb After First Dose(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)
- Part 1 - Cmax for Cysteine Maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) After First Dose(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)
- Part 2 - Cmax for Cys-mcMMAF After First Dose(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)
- Part 1 - C-EOI for Cys-mcMMAF After First Dose(EOI post belantamab mafodotin dose on Day 1 of Cycle 1)
- Part 2 - C-EOI for Cys-mcMMAF After First Dose(EOI post belantamab mafodotin dose on Day 1 of Cycle 1)
- Part 1 - Tmax for Cys-mcMMAF After First Dose(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)
- Part 1 - Cmax for Pembrolizumab After First Dose(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)
- Part 1 - AUC From Time 0 to 168 h After Dosing [AUC (0-168h)] for Cys-mcMMAF After First Dose(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)
- Part 2 - AUC (0-168 h) for Cys-mcMMAF After First Dose(Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, and Cycle 1 Day 8)
- Part 2 - Tmax for Cys-mcMMAF After First Dose(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)
- Part 1 - Tlast for Cys-mcMMAF After First Dose(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)
- Part 2 - Tlast for Cys-mcMMAF After First Dose(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)
- Part 2 - Cmax for Pembrolizumab After First Dose(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)
- Part 1 - Tmax for Pembrolizumab After First Dose(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)
- Part 2 - Tmax for Pembrolizumab After First Dose(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)
- Part 1 - AUC (0-tau) for Pembrolizumab After First Dose(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)
- Part 2 - Number of Participants With Post-baseline Positive ADAs Against Belantamab Mafodotin(Baseline (Day 1) and until end of treatment (up to 178 weeks))
- Part 2 - Titers of ADAs Against Belantamab Mafodotin(Baseline (Day 1) and up to approximately 178 weeks)
- Part 1 - Titers of ADAs Against Belantamab Mafodotin(Up to approximately 178 weeks)
- Part 2 - AUC (0-tau) for Pembrolizumab After First Dose(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)
- Part 1 - Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin(Baseline (Day 1) and until end of treatment (up to 178 weeks))