Trial Outcomes & Findings for A Study of SEA-CD40 Given With Other Drugs in Cancers (NCT NCT04993677)

Last Updated: 2025-05-11

Results Overview

cORR is defined as the percentage of participants achieving a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1. CR: disappearance of all target, non-target lesions, all lymph nodes must be non-pathological in size (\<10 millimeter \[mm\] short axis), PR: at least 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters persistence of one or more non-target lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

77 participants

Primary outcome timeframe

From start of study treatment until CR or PR (maximum up to 15.2 months)

Results posted on

2025-05-11

Participant Flow

This study planned to have 5 cohorts-Cohort 1: relapsed/refractory melanoma, Cohort 2: uveal melanoma, Cohort 3: programmed cell death 1 ligand 1 (PD-\[L\]1)-naive melanoma, Cohort 4: non-small cell lung cancer (NSCLC), programmed cell death ligand 1 (PD-L1) 1-49%, Cohort 5: NSCLC, PD-L1 \< 1%. No participant was enrolled and treated in Cohort 3.

"Study termination by sponsor" was used as end of study reason as long-term follow-up was discontinued following decision to close enrollment. Study status is listed completed as participants were permitted to receive treatment until they met protocol defined reasons to stop. After treatment discontinuation, participants were followed through duration of safety reporting period, and then ended study as no further disease or survival follow-up was required.

Participant milestones

Participant milestones
Measure	Cohort 1: Relapsed/Refractory Melanoma Participants with relapsed/refractory melanoma, were administered SEA-CD40 10 micrograms per kilogram (mcg/kg) as an intravenous (IV) infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 milligrams (mg) as an IV infusion on Day 8 of 42-day cycles.	Cohort 2: Uveal Melanoma Participants with uveal melanoma, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 mg as an IV infusion on Day 8 of 42-day cycles.	Cohort 4: NSCLC, PD-L1 1-49% Participants with NSCLC, PD-L1 1-49%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg per meter square (/m\^2) as an IV infusion on Day 1 of 21-day cycles and Carboplatin area under curve (AUC) 5 milligrams/milliliter/minute (mg/mL/min) as an IV infusion on Day 1 of 21-day (Cycles 1-4).	Cohort 5: NSCLC, PD-L1 < 1% Participants with NSCLC, PD-L1 \<1%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m\^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1-4).
Overall Study STARTED	21	39	9	8
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	21	39	9	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: Relapsed/Refractory Melanoma Participants with relapsed/refractory melanoma, were administered SEA-CD40 10 micrograms per kilogram (mcg/kg) as an intravenous (IV) infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 milligrams (mg) as an IV infusion on Day 8 of 42-day cycles.	Cohort 2: Uveal Melanoma Participants with uveal melanoma, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 mg as an IV infusion on Day 8 of 42-day cycles.	Cohort 4: NSCLC, PD-L1 1-49% Participants with NSCLC, PD-L1 1-49%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg per meter square (/m\^2) as an IV infusion on Day 1 of 21-day cycles and Carboplatin area under curve (AUC) 5 milligrams/milliliter/minute (mg/mL/min) as an IV infusion on Day 1 of 21-day (Cycles 1-4).	Cohort 5: NSCLC, PD-L1 < 1% Participants with NSCLC, PD-L1 \<1%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m\^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1-4).
Overall Study Lost to Follow-up	1	0	0	0
Overall Study Death	11	8	3	1
Overall Study Subject withdrawal of consent	4	3	0	2
Overall Study Study termination by sponsor	3	25	3	3
Overall Study Other	2	3	3	2

Baseline Characteristics

A Study of SEA-CD40 Given With Other Drugs in Cancers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: Relapsed/Refractory Melanoma n=21 Participants Participants with relapsed/refractory melanoma, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 mg as an IV infusion on Day 8 of 42-day cycles.	Cohort 2: Uveal Melanoma n=39 Participants Participants with uveal melanoma, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 mg as an IV infusion on Day 8 of 42-day cycles.	Cohort 4: NSCLC, PD-L1 1-49% n=9 Participants Participants with NSCLC, PD-L1 1-49%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m\^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1-4).	Cohort 5: NSCLC, PD-L1 < 1% n=8 Participants Participants with NSCLC, PD-L1 \<1%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m\^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1-4).	Total n=77 Participants Total of all reporting groups
Age, Continuous	64.3 Years STANDARD_DEVIATION 11.6 • n=5 Participants	62.3 Years STANDARD_DEVIATION 12.4 • n=7 Participants	64.6 Years STANDARD_DEVIATION 9.2 • n=5 Participants	66.8 Years STANDARD_DEVIATION 9.5 • n=4 Participants	63.6 Years STANDARD_DEVIATION 11.5 • n=21 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	20 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	35 Participants n=21 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	19 Participants n=7 Participants	5 Participants n=5 Participants	6 Participants n=4 Participants	42 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants	38 Participants n=7 Participants	9 Participants n=5 Participants	5 Participants n=4 Participants	68 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	5 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	39 Participants n=7 Participants	9 Participants n=5 Participants	5 Participants n=4 Participants	69 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	6 Participants n=21 Participants

PRIMARY outcome

Timeframe: From start of study treatment until CR or PR (maximum up to 15.2 months)

Population: The response evaluable (RE) analysis set included all participants with measurable disease at baseline who received any amount of study drug and had at least one post-baseline disease assessment per RECIST v1.1 or discontinued study treatment.

Outcome measures

Outcome measures
Measure	Cohort 1: Relapsed/Refractory Melanoma n=21 Participants Participants with relapsed/refractory melanoma, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 mg as an IV infusion on Day 8 of 42-day cycles.	Cohort 2: Uveal Melanoma n=39 Participants Participants with uveal melanoma, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 mg as an IV infusion on Day 8 of 42-day cycles.	Cohort 4: NSCLC, PD-L1 1-49% n=9 Participants Participants with NSCLC, PD-L1 1-49%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m\^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1-4).	Cohort 5: NSCLC, PD-L1 < 1% n=8 Participants Participants with NSCLC, PD-L1 \<1%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m\^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1-4).
Confirmed Objective Response Rate (cORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Per Investigator Assessment	0 Percentage of participants The upper and lower limit of 95% CI was not estimable since no participant had event.	5 Percentage of participants Interval 0.6 to 17.3	44 Percentage of participants Interval 13.7 to 78.8	25 Percentage of participants Interval 3.2 to 65.1

SECONDARY outcome

Timeframe: From first dose of the study treatment (Day 1) up to approximately 18.5 months

Population: The safety analysis set included all participants who received any amount of study drug.

Adverse event (AE):untoward medical occurrence in participant/clinical investigational participant administered medicinal product which doesn't necessarily have causal relationship with treatment. Serious AE (SAE):any AE that at any dose resulted in death, life threatening, required hospitalization/prolongation of hospitalization, disabling/incapacitating, congenital anomaly/birth defects.AEs included SAEs,non-SAEs.TEAEs:newly occurring/worsening after 1st dose of treatment.Treatment related TEAEs:related to treatment;relatedness judged by investigator. TEAEs graded according to National Cancer Institute Common Terminology Criteria for AEs (NCI-CTCAE) v4.03 (grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threating, grade 5=fatal). TESAEs:any TEAE that at any dose suspected to cause death, life-threatening, required hospitalization, disabling/incapacitating, congenital anomaly/birth defect. Treatment related TESAEs:related to treatment; relatedness judged by investigator.

Outcome measures

Outcome measures
Measure	Cohort 1: Relapsed/Refractory Melanoma n=21 Participants Participants with relapsed/refractory melanoma, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 mg as an IV infusion on Day 8 of 42-day cycles.	Cohort 2: Uveal Melanoma n=39 Participants Participants with uveal melanoma, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 mg as an IV infusion on Day 8 of 42-day cycles.	Cohort 4: NSCLC, PD-L1 1-49% n=9 Participants Participants with NSCLC, PD-L1 1-49%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m\^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1-4).	Cohort 5: NSCLC, PD-L1 < 1% n=8 Participants Participants with NSCLC, PD-L1 \<1%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m\^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1-4).
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Related TEAEs, Greater Than or Equal to (>=) Grade 3 TEAEs, Treatment Emergent Serious Adverse Event (TESAE), Treatment Related TESAE TEAE	17 Participants	37 Participants	8 Participants	8 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Related TEAEs, Greater Than or Equal to (>=) Grade 3 TEAEs, Treatment Emergent Serious Adverse Event (TESAE), Treatment Related TESAE Treatment-related TEAE	16 Participants	32 Participants	8 Participants	8 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Related TEAEs, Greater Than or Equal to (>=) Grade 3 TEAEs, Treatment Emergent Serious Adverse Event (TESAE), Treatment Related TESAE >= Grade 3 TEAEs	7 Participants	7 Participants	7 Participants	6 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Related TEAEs, Greater Than or Equal to (>=) Grade 3 TEAEs, Treatment Emergent Serious Adverse Event (TESAE), Treatment Related TESAE TESAE	4 Participants	5 Participants	5 Participants	5 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Related TEAEs, Greater Than or Equal to (>=) Grade 3 TEAEs, Treatment Emergent Serious Adverse Event (TESAE), Treatment Related TESAE Treatment-related TESAE	2 Participants	2 Participants	3 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline up to approximately 15.8 months

Population: The safety analysis set included all participants who received any amount of study drug.

In this outcome measure, number of participants with baseline laboratory chemistry values as per NCI-CTCAE grade (grade 0=within normal limits, grade 1=mild, grade 2=moderate, grade 3=severe, grade 4= life-threatening) and corresponding changes or shift to the worst CTC grades post baseline were presented. Laboratory parameters evaluated: alanine aminotransferase increased, albumin decreased, alkaline phosphatase increased, aspartate aminotransferase increased, calcium corrected for albumin, creatinine increased, glomerular filtration rate (GFR) estimated decreased, glucose decreased, lactate dehydrogenase increased, potassium, sodium, total bilirubin increased. Baseline was defined as last non-missing grade before first dose of study treatment and worst post-baseline value defined as worst value post study treatment. Only those categories in which at least 1 participant had data in any reporting group were reported.

Outcome measures

Outcome measures
Measure	Cohort 1: Relapsed/Refractory Melanoma n=21 Participants Participants with relapsed/refractory melanoma, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 mg as an IV infusion on Day 8 of 42-day cycles.	Cohort 2: Uveal Melanoma n=39 Participants Participants with uveal melanoma, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 mg as an IV infusion on Day 8 of 42-day cycles.	Cohort 4: NSCLC, PD-L1 1-49% n=9 Participants Participants with NSCLC, PD-L1 1-49%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m\^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1-4).	Cohort 5: NSCLC, PD-L1 < 1% n=8 Participants Participants with NSCLC, PD-L1 \<1%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m\^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1-4).
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE Total bilirubin - increased: baseline Grade 0 to maximum post-baseline Grade 1	1 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE Sodium - decreased: baseline Grade 0 to maximum post-baseline Grade 3	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE Sodium - decreased: baseline Grade 1 to maximum post-baseline Grade 0	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE Sodium - decreased: baseline Grade 1 to maximum post-baseline Grade 2	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE Total bilirubin - increased: baseline Grade 0 to maximum post-baseline Grade 3	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE Alanine aminotransferase - increased: baseline Grade 0 to maximum post-baseline Grade 1	2 Participants	7 Participants	3 Participants	3 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE Alanine aminotransferase - increased: baseline Grade 0 to maximum post-baseline Grade 2	0 Participants	3 Participants	1 Participants	0 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE Alanine aminotransferase - increased: baseline Grade 0 to maximum post-baseline Grade 3	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE Alanine aminotransferase - increased: baseline Grade 1 to maximum post-baseline Grade 0	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE Alanine aminotransferase - increased: baseline Grade 2 to maximum post-baseline Grade 0	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE Albumin - decreased: baseline Grade 0 to maximum post-baseline Grade 1	5 Participants	2 Participants	2 Participants	1 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE Albumin - decreased: baseline Grade 0 to maximum post-baseline Grade 2	1 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE Albumin - decreased: baseline Grade 1 to maximum post-baseline Grade 2	3 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE Alkaline phosphatase - increased: baseline Grade 0 to maximum post-baseline Grade 1	4 Participants	9 Participants	1 Participants	1 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE Alkaline phosphatase - increased: baseline Grade 1 to maximum post-baseline Grade 0	1 Participants	3 Participants	1 Participants	2 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE Alkaline phosphatase - increased: baseline Grade 1 to maximum post-baseline Grade 2	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE Alkaline phosphatase - increased: baseline Grade 2 to maximum post-baseline Grade 0	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE Aspartate aminotransferase - increased: baseline Grade 0 to maximum post-baseline Grade 1	5 Participants	14 Participants	3 Participants	4 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE Aspartate aminotransferase - increased: baseline Grade 0 to maximum post-baseline Grade 2	1 Participants	2 Participants	1 Participants	0 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE Aspartate aminotransferase - increased: baseline Grade 1 to maximum post-baseline Grade 0	0 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE Aspartate aminotransferase - increased: baseline Grade 1 to maximum post-baseline Grade 2	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE Calcium corrected for albumin - decreased: baseline Grade 0 to maximum post-baseline Grade 1	2 Participants	1 Participants	4 Participants	1 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE Calcium corrected for albumin - decreased: baseline Grade 0 to maximum post-baseline Grade 2	0 Participants	0 Participants	1 Participants	2 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE Calcium corrected for albumin - decreased: baseline Grade 2 to maximum post-baseline Grade 1	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE Calcium corrected for albumin - increased: baseline Grade 0 to maximum post-baseline Grade 1	0 Participants	9 Participants	0 Participants	0 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE Creatinine - increased: baseline Grade 0 to maximum post-baseline Grade 1	3 Participants	5 Participants	1 Participants	2 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE Creatinine - increased: baseline Grade 0 to maximum post-baseline Grade 2	1 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE Creatinine - increased: baseline Grade 0 to maximum post-baseline Grade 3	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE Creatinine - increased: baseline Grade 1 to maximum post-baseline Grade 2	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE Glucose - decreased: baseline Grade 0 to maximum post-baseline Grade 1	0 Participants	3 Participants	0 Participants	2 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE Lactate dehydrogenase - increased: baseline Grade 0 to maximum post-baseline Grade 1	3 Participants	22 Participants	3 Participants	4 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE Lactate dehydrogenase - increased: baseline Grade 1 to maximum post-baseline Grade 0	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE Potassium - decreased: baseline Grade 0 to maximum post-baseline Grade 1	3 Participants	4 Participants	2 Participants	1 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE Potassium - decreased: baseline Grade 0 to maximum post-baseline Grade 3	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE Potassium - decreased: baseline Grade 1 to maximum post-baseline Grade 0	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE Potassium - increased: baseline Grade 0 to maximum post-baseline Grade 1	1 Participants	4 Participants	0 Participants	1 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE Potassium - increased: baseline Grade 0 to maximum post-baseline Grade 2	0 Participants	4 Participants	1 Participants	1 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE Sodium - decreased: baseline Grade 0 to maximum post-baseline Grade 1	7 Participants	10 Participants	3 Participants	3 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE Sodium - decreased: baseline Grade 0 to maximum post-baseline Grade 2	1 Participants	2 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline up to approximately 15.8 months

Population: The safety analysis set included all participants who received any amount of study drug.

In this outcome measure, number of participants with baseline laboratory hematology values as per NCI-CTCAE grade (grade 0= within normal limits, grade 1=mild, grade 2=moderate, grade 3= severe, grade 4= life-threatening) and corresponding changes or shift to the worst CTC grades post baseline were presented. Laboratory parameters evaluated: hemoglobin- decreased and increased, leukocytes- decreased and increased, lymphocytes- decreased and increased, neutrophils decreased, platelets decreased. Baseline was defined as last non-missing grade before first dose of study treatment and worst post-baseline value defined as worst value post study treatment. Only those categories in which at least 1 participant had data in any reporting group were reported.

Outcome measures

Outcome measures
Measure	Cohort 1: Relapsed/Refractory Melanoma n=21 Participants Participants with relapsed/refractory melanoma, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 mg as an IV infusion on Day 8 of 42-day cycles.	Cohort 2: Uveal Melanoma n=39 Participants Participants with uveal melanoma, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 mg as an IV infusion on Day 8 of 42-day cycles.	Cohort 4: NSCLC, PD-L1 1-49% n=9 Participants Participants with NSCLC, PD-L1 1-49%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m\^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1-4).	Cohort 5: NSCLC, PD-L1 < 1% n=8 Participants Participants with NSCLC, PD-L1 \<1%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m\^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1-4).
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE Hemoglobin - decreased: baseline Grade 0 to maximum post-baseline Grade 3	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE Neutrophils - decreased: baseline Grade 0 to maximum post-baseline Grade 1	1 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE Hemoglobin - decreased: baseline Grade 1 to maximum post-baseline Grade 3	1 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE Hemoglobin - decreased: baseline Grade 0 to maximum post-baseline Grade 1	7 Participants	11 Participants	4 Participants	2 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE Hemoglobin - decreased: baseline Grade 0 to maximum post-baseline Grade 2	0 Participants	0 Participants	2 Participants	1 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE Hemoglobin - decreased: baseline Grade 1 to maximum post-baseline Grade 2	3 Participants	1 Participants	0 Participants	3 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE Hemoglobin - decreased: baseline Grade 2 to maximum post-baseline Grade 1	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE Hemoglobin - increased: baseline Grade 0 to maximum post-baseline Grade 1	0 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE Leukocytes - decreased: baseline Grade 0 to maximum post-baseline Grade 1	1 Participants	3 Participants	2 Participants	4 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE Leukocytes - decreased: baseline Grade 0 to maximum post-baseline Grade 2	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE Leukocytes - decreased: baseline Grade 0 to maximum post-baseline Grade 3	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE Lymphocytes - decreased: baseline Grade 0 to maximum post-baseline Grade 1	2 Participants	9 Participants	1 Participants	1 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE Lymphocytes - decreased: baseline Grade 0 to maximum post-baseline Grade 2	4 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE Lymphocytes - decreased: baseline Grade 0 to post-baseline Grade 3	1 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE Lymphocytes - decreased: baseline Grade 0 to maximum post-baseline Grade 4	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE Lymphocytes - decreased: baseline Grade 1 to maximum post-baseline Grade 2	1 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE Lymphocytes - decreased: baseline Grade 1 to maximum post-baseline Grade 3	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE Lymphocytes - decreased: baseline Grade 2 to maximum post-baseline Grade 3	0 Participants	2 Participants	1 Participants	0 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE Lymphocytes - decreased: baseline Grade 3 to maximum post-baseline Grade 4	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE Lymphocytes - increased: baseline Grade 0 to maximum post-baseline Grade 2	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE Neutrophils - decreased: baseline Grade 0 to maximum post-baseline Grade 2	0 Participants	0 Participants	2 Participants	1 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE Neutrophils - decreased: baseline Grade 0 to maximum post-baseline Grade 3	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE Platelets - decreased: baseline Grade 0 to maximum post-baseline Grade 1	1 Participants	1 Participants	4 Participants	3 Participants

SECONDARY outcome

Timeframe: From first dose of the study treatment (Day 1) up to approximately 18.5 months

Population: The safety analysis set included all participants who received any amount of study drug.

An AE is defined as any untoward medical occurrence in participant/clinical investigational participant administered medicinal product which doesn't necessarily have causal relationship with treatment. Number of participants with dose interruption (SEA-CD40 treatment being temporarily stopped), dose reduction (SEA-CD40 decrease in dose) and dose discontinuation (SEA-CD40 treatment permanently stopped) due to adverse events were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Cohort 1: Relapsed/Refractory Melanoma n=21 Participants Participants with relapsed/refractory melanoma, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 mg as an IV infusion on Day 8 of 42-day cycles.	Cohort 2: Uveal Melanoma n=39 Participants Participants with uveal melanoma, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 mg as an IV infusion on Day 8 of 42-day cycles.	Cohort 4: NSCLC, PD-L1 1-49% n=9 Participants Participants with NSCLC, PD-L1 1-49%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m\^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1-4).	Cohort 5: NSCLC, PD-L1 < 1% n=8 Participants Participants with NSCLC, PD-L1 \<1%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m\^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1-4).
Number of Participants With Treatment Interruptions, Dose Reductions, Treatment Discontinuations Due to Adverse Events Treatment interruptions	1 Participants	5 Participants	2 Participants	1 Participants
Number of Participants With Treatment Interruptions, Dose Reductions, Treatment Discontinuations Due to Adverse Events Dose reductions	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Interruptions, Dose Reductions, Treatment Discontinuations Due to Adverse Events Treatment discontinuations	2 Participants	0 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: From the first dose of study treatment until the first documented CR, PR or SD or new anticancer therapies or death, whichever occurred first (maximum up to 15.2 months)

Population: The RE analysis set included all participants with measurable disease at baseline who received any amount of study drug and had at least one post-baseline disease assessment per RECIST v1.1 or discontinued study treatment.

DCR is defined as the percentage of participants who achieved a confirmed CR or PR according to RECIST v1.1 as assessed by the investigator or met the stable disease (SD) criteria at least once after start of study treatment at a minimum interval of 5 weeks. CR: disappearance of all target, non-target lesions, all lymph nodes must be non-pathological in size (\<10 mm short axis), PR: at least 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters persistence of one or more non-target lesions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase in lesions to qualify for progressive disease (PD) referring smallest sum diameter, PD: at least 20% increase (including absolute increase of at least 5 mm) in sum of diameters of target lesions, taking reference smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.

Outcome measures

Outcome measures
Measure	Cohort 1: Relapsed/Refractory Melanoma n=21 Participants Participants with relapsed/refractory melanoma, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 mg as an IV infusion on Day 8 of 42-day cycles.	Cohort 2: Uveal Melanoma n=39 Participants Participants with uveal melanoma, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 mg as an IV infusion on Day 8 of 42-day cycles.	Cohort 4: NSCLC, PD-L1 1-49% n=9 Participants Participants with NSCLC, PD-L1 1-49%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m\^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1-4).	Cohort 5: NSCLC, PD-L1 < 1% n=8 Participants Participants with NSCLC, PD-L1 \<1%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m\^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1-4).
Disease Control Rate (DCR) Per Investigator Assessment	48 Percentage of participants Interval 25.7 to 70.2	62 Percentage of participants Interval 44.6 to 76.6	67 Percentage of participants Interval 29.9 to 92.5	88 Percentage of participants Interval 47.3 to 99.7

SECONDARY outcome

Timeframe: From the first documentation of CR or PR to PD or death due to any cause or censoring, whichever occurred first (maximum up to 11.1 months)

DOR: time from first documentation of OR (confirmed CR or PR) to first documentation of PD or death due to any cause, whichever occurred first. Per RECIST v1.1- CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR: \>=30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. Participants with no PD and were still on study at time of analysis or were removed from study prior to documentation of PD were censored at last disease assessment documenting absence of PD. Participants who started new anticancer treatment prior to documentation of PD were censored at last disease assessment prior to start of new treatment. PD: at least 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study. In addition to relative increase of 20%, sum must demonstrate absolute increase of 0.5 cm. Appearance of 1 or more new lesions. Kaplan-Meier method was used.

Outcome measures

Outcome measures
Measure	Cohort 1: Relapsed/Refractory Melanoma Participants with relapsed/refractory melanoma, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 mg as an IV infusion on Day 8 of 42-day cycles.	Cohort 2: Uveal Melanoma n=2 Participants Participants with uveal melanoma, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 mg as an IV infusion on Day 8 of 42-day cycles.	Cohort 4: NSCLC, PD-L1 1-49% n=4 Participants Participants with NSCLC, PD-L1 1-49%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m\^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1-4).	Cohort 5: NSCLC, PD-L1 < 1% n=2 Participants Participants with NSCLC, PD-L1 \<1%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m\^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1-4).
Duration of Response (DOR) Per Investigator Assessment	—	NA Months Interval 5.6 to Median and upper limit of the 95% confidence interval was not estimable due to insufficient number of participants with events.	11.1 Months Interval 9.9 to Upper limit of the 95% confidence interval was not estimable due to insufficient number of participants with events.	2.1 Months Lower and upper limit of the 95% confidence interval was not estimable due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: From first dose of study treatment to the date of PD or death due to any cause or censoring, whichever occurred first (maximum up to 13.9 months)

Population: The full analysis set (FAS) includes all participants who received any amount of study drug.

PFS is defined as time from start of study treatment to first documentation of PD by RECIST v1.1 or death due to any cause, whichever occurred first. Participants with no PD and were still on study at time of analysis or who were removed from study prior to documentation of PD were censored at the date of last disease assessment documenting absence of PD. Participants who started new anticancer treatment prior to documentation of PD were censored at date of last disease assessment prior to start of new treatment. PD: At least 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study (this included baseline sum if that is the smallest on study). In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 0.5 cm. Appearance of one or more new lesions was also considered progression. Kaplan-Meier method was used.

Outcome measures

Outcome measures
Measure	Cohort 1: Relapsed/Refractory Melanoma n=21 Participants Participants with relapsed/refractory melanoma, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 mg as an IV infusion on Day 8 of 42-day cycles.	Cohort 2: Uveal Melanoma n=39 Participants Participants with uveal melanoma, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 mg as an IV infusion on Day 8 of 42-day cycles.	Cohort 4: NSCLC, PD-L1 1-49% n=9 Participants Participants with NSCLC, PD-L1 1-49%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m\^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1-4).	Cohort 5: NSCLC, PD-L1 < 1% n=8 Participants Participants with NSCLC, PD-L1 \<1%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m\^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1-4).
Progression Free Survival (PFS) Per Investigator Assessment	1.6 Months Interval 1.4 to 2.9	4.0 Months Interval 1.4 to 8.2	13.8 Months Interval 1.4 to Upper limit of the 95% confidence interval was not estimable due to insufficient number of participants with events.	5.5 Months Interval 1.4 to Upper limit of the 95% confidence interval was not estimable due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: From start of study treatment to death due to any cause or censoring date (maximum up to 23.6 months)

Population: The FAS includes all participants who received any amount of study drug.

OS is defined as the time from the start of study treatment to date of death due to any cause. In the absence of death, survival time was censored at the last date the participant was known to be alive. Kaplan-Meier method was used for analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Relapsed/Refractory Melanoma n=21 Participants Participants with relapsed/refractory melanoma, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 mg as an IV infusion on Day 8 of 42-day cycles.	Cohort 2: Uveal Melanoma n=39 Participants Participants with uveal melanoma, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 mg as an IV infusion on Day 8 of 42-day cycles.	Cohort 4: NSCLC, PD-L1 1-49% n=9 Participants Participants with NSCLC, PD-L1 1-49%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m\^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1-4).	Cohort 5: NSCLC, PD-L1 < 1% n=8 Participants Participants with NSCLC, PD-L1 \<1%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m\^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1-4).
Overall Survival (OS)	11.0 Months Interval 5.3 to 18.7	NA Months Interval 16.7 to Median and upper limit of the 95% confidence interval was not estimable due to insufficient number of participants with events.	18.0 Months Interval 2.5 to Upper limit of the 95% confidence interval was not estimable due to insufficient number of participants with events.	NA Months Interval 3.2 to Median and upper limit of the 95% confidence interval was not estimable due to insufficient number of participants with events.

Adverse Events

Cohort 1: Relapsed/Refractory Melanoma

Serious events: 4 serious events

Other events: 17 other events

Deaths: 11 deaths

Cohort 2: Uveal Melanoma

Serious events: 5 serious events

Other events: 37 other events

Deaths: 8 deaths

Cohort 4: NSCLC, PD-L1 1-49%

Serious events: 5 serious events

Other events: 8 other events

Deaths: 3 deaths

Cohort 5: NSCLC, PD-L1 < 1%

Serious events: 5 serious events

Other events: 7 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place