Trial Outcomes & Findings for A Phase Ib Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of Avelumab in Combination With M9241(NHS-IL12) (JAVELIN IL-12) (NCT NCT02994953)

Last Updated: 2024-09-20

Results Overview

An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. Serious AE: an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAE: AE with onset after start of treatment or with onset date before the treatment start date but worsening after the treatment start date. TEAEs included both serious and non-serious TEAEs. Treatment-related TEAEs: reasonably related to the study intervention. Number of participants with TEAEs and treatment related TEAEs were reported.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

52 participants

Primary outcome timeframe

From first dose of study treatment up to 1311 days

Results posted on

2024-09-20

Participant Flow

The study consisted of 2 parts: Part A (Dose escalation) and Part B (Dose expansion).

The study was conducted at 33 sites within Europe and the United States.

Participant milestones

Participant milestones
Measure	Part A Cohort 1: M9241 4 mcg/kg + Avelumab 10 mg/kg (Experimental) Participants received M9241 at a dose of 4 micrograms per kilogram (mcg/kg) a subcutaneous (SC) injection at time (up to -20 minutes) relative to the start of Avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 2 weeks on Day 1 and 15 during each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 2: M9241 8 mcg/kg + Avelumab 10 mg/kg (Experimental) Participants received M9241 at a dose of 8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 3: M9241 12 mcg/kg + Avelumab 10 mg/kg (Experimental) Participants received M9241 at a dose of 12 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 4: M9241 16.8 mcg/kg +Avelumab 10 mg/kg (Experimental) Participants received M9241 at a dose of 16.8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 5: M9241 16.8 mcg/kg + Avelumab 800 mg (Experimental) Participants received M9241 at a dose of 16.8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 800 milligrams (mg) IV infusion once weekly for the first 12 weeks, then 800 mg once every 2 weeks of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part B Cohort 1: UC Cohort Stage 1 Combination Therapy (Experimental) Participants in the expansion cohorts received M9241 at dose of 16.8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks on Day 1 in combination with Avelumab 800 mg IV infusion once weekly for the first 12 weeks, then 800 mg once every 2 weeks of each cycle (Each cycle=28 days) determined as the RP2D in the escalation part of the study.
Overall Study STARTED	9	7	7	6	7	16
Overall Study COMPLETED	9	7	7	6	7	16
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase Ib Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of Avelumab in Combination With M9241(NHS-IL12) (JAVELIN IL-12)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A Cohort 1: M9241 4 mcg/kg + Avelumab 10 mg/kg (Experimental) n=9 Participants Participants received M9241 at a dose of 4 micrograms per kilogram (mcg/kg) a subcutaneous (SC) injection at time (up to -20 minutes) relative to the start of Avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 2 weeks on Day 1 and 15 during each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 2: M9241 8 mcg/kg + Avelumab 10 mg/kg (Experimental) n=7 Participants Participants received M9241 at a dose of 8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 3: M9241 12 mcg/kg + Avelumab 10 mg/kg (Experimental) n=7 Participants Participants received M9241 at a dose of 12 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 4: M9241 16.8 mcg/kg +Avelumab 10 mg/kg (Experimental) n=6 Participants Participants received M9241 at a dose of 16.8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 5: M9241 16.8 mcg/kg + Avelumab 800 mg (Experimental) n=7 Participants Participants received M9241 at a dose of 16.8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 800 milligrams (mg) IV infusion once weekly for the first 12 weeks, then 800 mg once every 2 weeks of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part B Cohort 1: UC Cohort Stage 1 Combination Therapy (Experimental) n=16 Participants Participants in the expansion cohorts received M9241 at dose of 16.8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks on Day 1 in combination with Avelumab 800 mg IV infusion once weekly for the first 12 weeks, then 800 mg once every 2 weeks of each cycle (Each cycle=28 days) determined as the RP2D in the escalation part of the study.	Total n=52 Participants Total of all reporting groups
Age, Categorical <=18 years	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	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	5 Participants n=21 Participants	8 Participants n=8 Participants	32 Participants n=8 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	8 Participants n=8 Participants	20 Participants n=8 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	4 Participants n=8 Participants	18 Participants n=8 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	5 Participants n=21 Participants	12 Participants n=8 Participants	34 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=8 Participants	2 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	6 Participants n=4 Participants	5 Participants n=21 Participants	16 Participants n=8 Participants	48 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	2 Participants n=8 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	0 Participants n=8 Participants	0 Participants n=8 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	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 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	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	3 Participants n=8 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	8 Participants n=8 Participants	38 Participants n=8 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	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	8 Participants n=8 Participants	10 Participants n=8 Participants

PRIMARY outcome

Timeframe: From first dose of study treatment up to 1311 days

Population: Safety analysis set (SAF) included all participants who receive at least 1 dose (complete or incomplete) of any investigational medicinal product (IMP) (Avelumab or NHS-IL12).

Outcome measures

Outcome measures
Measure	Part A Cohort 1: M9241 4 mcg/kg + Avelumab 10 mg/kg n=9 Participants Participants received M9241 at a dose of 4 micrograms per kilogram (mcg/kg) a subcutaneous (SC) injection at time (up to -20 minutes) relative to the start of Avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 2 weeks on Day 1 and 15 during each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 2: M9241 8 mcg/kg + Avelumab 10 mg/kg n=7 Participants Participants received M9241 at a dose of 8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 3: M9241 12 mcg/kg + Avelumab 10 mg/kg n=7 Participants Participants received M9241 at a dose of 12 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 4: M9241 16.8 mcg/kg +Avelumab 10 mg/kg n=6 Participants Participants received M9241 at a dose of 16.8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 5: M9241 16.8 mcg/kg + Avelumab 800 mg n=7 Participants Participants received M9241 at a dose of 16.8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 800 milligrams (mg) IV infusion once weekly for the first 12 weeks, then 800 mg once every 2 weeks of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.
Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Event (NCI-CTCAE) v4.03 Participants with TEAEs	9 Participants	7 Participants	7 Participants	6 Participants	7 Participants
Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Event (NCI-CTCAE) v4.03 Participants with Treatment-related-TEAEs	8 Participants	5 Participants	6 Participants	5 Participants	6 Participants

PRIMARY outcome

Timeframe: Part B: From first dose of study treatment up to 443 days

Population: SAF included all participants who receive at least 1 dose of any investigational medicinal product (IMP) (Avelumab or NHS-IL12).

Outcome measures

Outcome measures
Measure	Part A Cohort 1: M9241 4 mcg/kg + Avelumab 10 mg/kg n=16 Participants Participants received M9241 at a dose of 4 micrograms per kilogram (mcg/kg) a subcutaneous (SC) injection at time (up to -20 minutes) relative to the start of Avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 2 weeks on Day 1 and 15 during each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 2: M9241 8 mcg/kg + Avelumab 10 mg/kg Participants received M9241 at a dose of 8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 3: M9241 12 mcg/kg + Avelumab 10 mg/kg Participants received M9241 at a dose of 12 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 4: M9241 16.8 mcg/kg +Avelumab 10 mg/kg Participants received M9241 at a dose of 16.8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 5: M9241 16.8 mcg/kg + Avelumab 800 mg Participants received M9241 at a dose of 16.8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 800 milligrams (mg) IV infusion once weekly for the first 12 weeks, then 800 mg once every 2 weeks of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.
Part B: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Event (NCI-CTCAE) v4.03 Participants with TEAEs	16 Participants	—	—	—	—
Part B: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Event (NCI-CTCAE) v4.03 Participants with Treatment-Related AEs	15 Participants	—	—	—	—

PRIMARY outcome

Timeframe: From first dose of study treatment up to 1311 days

Population: SAF analysis set included all participants who receive at least 1 dose (complete or incomplete) of any IMP (Avelumab or NHS-IL12).

AE was any untoward medical occurrence in a participants who received study drug without regard to possibility of causal relationship. An AE was considered treatment emergent if occurred for the first time after the start of study treatment or occurred prior to the start of treatment. Severity of TEAEs were graded using NCI-CTCAE v4.03 toxicity grades, as follows: Grade 3 = Severe; Grade 4 = Life-threatening and Grade 5 = Death. Number of participants with Grade 3,4 and 5 by severity were only reported.

Outcome measures

Outcome measures
Measure	Part A Cohort 1: M9241 4 mcg/kg + Avelumab 10 mg/kg n=9 Participants Participants received M9241 at a dose of 4 micrograms per kilogram (mcg/kg) a subcutaneous (SC) injection at time (up to -20 minutes) relative to the start of Avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 2 weeks on Day 1 and 15 during each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 2: M9241 8 mcg/kg + Avelumab 10 mg/kg n=7 Participants Participants received M9241 at a dose of 8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 3: M9241 12 mcg/kg + Avelumab 10 mg/kg n=7 Participants Participants received M9241 at a dose of 12 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 4: M9241 16.8 mcg/kg +Avelumab 10 mg/kg n=6 Participants Participants received M9241 at a dose of 16.8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 5: M9241 16.8 mcg/kg + Avelumab 800 mg n=7 Participants Participants received M9241 at a dose of 16.8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 800 milligrams (mg) IV infusion once weekly for the first 12 weeks, then 800 mg once every 2 weeks of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.
Part A: Number of Participants With Treatment-Related Adverse Events (TRAEs) by Severity Based on Grade 3,4 and 5 According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03) Grade 5	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Part A: Number of Participants With Treatment-Related Adverse Events (TRAEs) by Severity Based on Grade 3,4 and 5 According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03) Grade >=3	6 Participants	5 Participants	6 Participants	4 Participants	4 Participants
Part A: Number of Participants With Treatment-Related Adverse Events (TRAEs) by Severity Based on Grade 3,4 and 5 According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03) Grade >=4	2 Participants	2 Participants	2 Participants	2 Participants	1 Participants

PRIMARY outcome

Timeframe: First dose of study drug up to 443 days

Population: SAF analysis set included all participants who receive at least 1 dose (complete or incomplete) of any IMP (Avelumab or NHS-IL12). Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

AE was any untoward medical occurrence in a participants who received study drug without regard to possibility of causal relationship. An AE was considered treatment emergent if occurred for the first time after the start of study treatment or occurred prior to the start of treatment. Severity of TEAEs were graded using NCI-CTCAE v4.03 toxicity grades, as follows: Grade 1= Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening and Grade 5 = Death. Number of participants with TEAEs and TRAEs by severity were reported.

Outcome measures

Outcome measures
Measure	Part A Cohort 1: M9241 4 mcg/kg + Avelumab 10 mg/kg n=15 Participants Participants received M9241 at a dose of 4 micrograms per kilogram (mcg/kg) a subcutaneous (SC) injection at time (up to -20 minutes) relative to the start of Avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 2 weeks on Day 1 and 15 during each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 2: M9241 8 mcg/kg + Avelumab 10 mg/kg Participants received M9241 at a dose of 8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 3: M9241 12 mcg/kg + Avelumab 10 mg/kg Participants received M9241 at a dose of 12 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 4: M9241 16.8 mcg/kg +Avelumab 10 mg/kg Participants received M9241 at a dose of 16.8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 5: M9241 16.8 mcg/kg + Avelumab 800 mg Participants received M9241 at a dose of 16.8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 800 milligrams (mg) IV infusion once weekly for the first 12 weeks, then 800 mg once every 2 weeks of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.
Part B: Number of Participants With Treatment-Related Adverse Events (TRAEs) by Severity According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03) Grade >=4	1 Participants	—	—	—	—
Part B: Number of Participants With Treatment-Related Adverse Events (TRAEs) by Severity According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03) Any Grade	15 Participants	—	—	—	—
Part B: Number of Participants With Treatment-Related Adverse Events (TRAEs) by Severity According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03) Grade >=3	8 Participants	—	—	—	—
Part B: Number of Participants With Treatment-Related Adverse Events (TRAEs) by Severity According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03) Grade 5	0 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Time from first treatment to final assessment up to 3 weeks

Population: DLTs analysis set included all participants who received all treatment in the DLT period or stopped treatment because of DLTs in the DLT period.

A DLT is any Grade (\>=) 3 non-hematologic AE or any Grade (\>=) 4 hematologic AE according to the NCI-CTCAE v4.03, occurring during the DLT observation period that is related to either or both study drugs as determined by the Investigator or Sponsor at any dose and judged not to be related to the underlying disease or any previous or concomitant medication. The following are exceptions to the DLTs: Grade \>=3 thrombocytopenia with medically concerning bleeding; Any Grade 3 autoimmune thyroid-related toxicity that doesn't clinically resolve to \<= Grade 2 within 7 days of initiating therapy will be a DLT. Any Grade 4 neutropenia of \< 5 days duration; Grade 3 infusion-related reaction resolving within 6 hours of infusion; Grade 3 diarrhea or skin toxicity that resolves to Grade \<= 1 within 7 days after medical management; Transient Grade 3 fatigue, local reactions, flu-like symptoms; Tumor flare phenomenon of known or suspected tumor did not consider a DLT.

Outcome measures

Outcome measures
Measure	Part A Cohort 1: M9241 4 mcg/kg + Avelumab 10 mg/kg n=7 Participants Participants received M9241 at a dose of 4 micrograms per kilogram (mcg/kg) a subcutaneous (SC) injection at time (up to -20 minutes) relative to the start of Avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 2 weeks on Day 1 and 15 during each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 2: M9241 8 mcg/kg + Avelumab 10 mg/kg n=6 Participants Participants received M9241 at a dose of 8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 3: M9241 12 mcg/kg + Avelumab 10 mg/kg n=6 Participants Participants received M9241 at a dose of 12 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 4: M9241 16.8 mcg/kg +Avelumab 10 mg/kg n=6 Participants Participants received M9241 at a dose of 16.8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 5: M9241 16.8 mcg/kg + Avelumab 800 mg n=7 Participants Participants received M9241 at a dose of 16.8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 800 milligrams (mg) IV infusion once weekly for the first 12 weeks, then 800 mg once every 2 weeks of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.
Part A: Number of Participants Experiencing Dose Limiting Toxicities (DLTs)	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: First dose of study drug up to 443 days

Population: Full analysis set included all participants who received at least 1 dose of any study treatment.

Confirmed BOR was defined as the best response of any of the confirmed complete response (CR), confirmed partial response (PR), stable disease (SD) and progressive disease (PD) recorded from the date of randomization until disease progression or recurrence (taking the smallest measurement recorded since the start of treatment as reference).CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Stable disease (SD)= Neither sufficient increase to qualify for progression of disease (PD) nor sufficient shrinkage to qualify for PR. PD: At least a 20 % increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. Not evaluable (NE): No post-baseline assessment. BOR assessments were assessed by investigators.

Outcome measures

Outcome measures
Measure	Part A Cohort 1: M9241 4 mcg/kg + Avelumab 10 mg/kg n=16 Participants Participants received M9241 at a dose of 4 micrograms per kilogram (mcg/kg) a subcutaneous (SC) injection at time (up to -20 minutes) relative to the start of Avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 2 weeks on Day 1 and 15 during each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 2: M9241 8 mcg/kg + Avelumab 10 mg/kg Participants received M9241 at a dose of 8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 3: M9241 12 mcg/kg + Avelumab 10 mg/kg Participants received M9241 at a dose of 12 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 4: M9241 16.8 mcg/kg +Avelumab 10 mg/kg Participants received M9241 at a dose of 16.8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 5: M9241 16.8 mcg/kg + Avelumab 800 mg Participants received M9241 at a dose of 16.8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 800 milligrams (mg) IV infusion once weekly for the first 12 weeks, then 800 mg once every 2 weeks of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.
Part B: Number of Participants With Confirmed Best Overall Response (BOR) Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Complete Response	0 Participants	—	—	—	—
Part B: Number of Participants With Confirmed Best Overall Response (BOR) Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Partial Response	0 Participants	—	—	—	—
Part B: Number of Participants With Confirmed Best Overall Response (BOR) Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Stable Disease	2 Participants	—	—	—	—
Part B: Number of Participants With Confirmed Best Overall Response (BOR) Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Progressive Disease	13 Participants	—	—	—	—
Part B: Number of Participants With Confirmed Best Overall Response (BOR) Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Not evaluable	1 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Predose (PrD),1,4,8 hours postdose (PD) on Day 1,22 of Cycle 1 & 2; PrD,1 hour PD on Day 8,15 of Cycle 1 & Day 8,15,22 of Cycle 2; PrD, 1 hour PD on Day 1 Cycle 3 & Day 1,15 of Cycle 4; PrD on Day 1 of Cycle 7,10,13,16,19,22,25, & 28 (Each cycle: 28 days)

Population: Pharmacokinetic analysis set included all participants who completed at least 1 administration of avelumab and/or M9241, and who provided at least 1 sample with a measurable concentration of avelumab or M9241. Here, "Overall Number of participants analyzed", signifies those participants who were evaluable for this outcome measure and "Number analyzed" signifies those participants who were evaluable at the specified time point.

Area under the serum concentration versus time curve from time zero to the last sampling time t at which concentration is at or above the lower limit of quantification (LLLQ). AUC0-t was calculated according to the mixed log-linear trapezoidal rule.

Outcome measures

Outcome measures
Measure	Part A Cohort 1: M9241 4 mcg/kg + Avelumab 10 mg/kg n=8 Participants Participants received M9241 at a dose of 4 micrograms per kilogram (mcg/kg) a subcutaneous (SC) injection at time (up to -20 minutes) relative to the start of Avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 2 weeks on Day 1 and 15 during each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 2: M9241 8 mcg/kg + Avelumab 10 mg/kg n=7 Participants Participants received M9241 at a dose of 8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 3: M9241 12 mcg/kg + Avelumab 10 mg/kg n=7 Participants Participants received M9241 at a dose of 12 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 4: M9241 16.8 mcg/kg +Avelumab 10 mg/kg n=6 Participants Participants received M9241 at a dose of 16.8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 5: M9241 16.8 mcg/kg + Avelumab 800 mg n=7 Participants Participants received M9241 at a dose of 16.8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 800 milligrams (mg) IV infusion once weekly for the first 12 weeks, then 800 mg once every 2 weeks of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.
Part A: Area Under Serum Concentration Time Curve From Time Zero to the Time of the Last Observation (AUC0-t) of Avelumab Cycle 2 Day 1	26400 microgramhour per milliliter (mcgh/mL) Geometric Coefficient of Variation 17.2	27900 microgramhour per milliliter (mcgh/mL) Geometric Coefficient of Variation 47.9	22700 microgramhour per milliliter (mcgh/mL) Geometric Coefficient of Variation 23.2	22700 microgramhour per milliliter (mcgh/mL) Geometric Coefficient of Variation 10.5	22100 microgramhour per milliliter (mcgh/mL) Geometric Coefficient of Variation 42.7
Part A: Area Under Serum Concentration Time Curve From Time Zero to the Time of the Last Observation (AUC0-t) of Avelumab Cycle 1 Day 1	20700 microgramhour per milliliter (mcgh/mL) Geometric Coefficient of Variation 38.1	26600 microgramhour per milliliter (mcgh/mL) Geometric Coefficient of Variation 57.9	23600 microgramhour per milliliter (mcgh/mL) Geometric Coefficient of Variation 16.6	17400 microgramhour per milliliter (mcgh/mL) Geometric Coefficient of Variation 33.4	17900 microgramhour per milliliter (mcgh/mL) Geometric Coefficient of Variation 39.7
Part A: Area Under Serum Concentration Time Curve From Time Zero to the Time of the Last Observation (AUC0-t) of Avelumab Cycle 1 Day 15	22800 microgramhour per milliliter (mcgh/mL) Geometric Coefficient of Variation 40.5	26100 microgramhour per milliliter (mcgh/mL) Geometric Coefficient of Variation 42.5	28300 microgramhour per milliliter (mcgh/mL) Geometric Coefficient of Variation 39.4	22000 microgramhour per milliliter (mcgh/mL) Geometric Coefficient of Variation 19.2	—
Part A: Area Under Serum Concentration Time Curve From Time Zero to the Time of the Last Observation (AUC0-t) of Avelumab Cycle 1 Day 22	—	—	—	—	26300 microgramhour per milliliter (mcgh/mL) Geometric Coefficient of Variation 31.0
Part A: Area Under Serum Concentration Time Curve From Time Zero to the Time of the Last Observation (AUC0-t) of Avelumab Cycle 4 Day 1	—	—	—	—	NA microgramhour per milliliter (mcgh/mL) Geometric Coefficient of Variation NA Based on pre-specified criteria, statistical analysis for PK was only performed if more than 3 participants have reportable parameter values.

SECONDARY outcome

Timeframe: PrD, 1, 4, 8 hours PD on Day 1, 22 of cycle 1 & 2; PrD, 1 hour PD on Day 8, 15 of cycle 1 & Day 8, 15, 22 of cycle 2; PrD, 1 hour PD on Day 1 cycle 3 & Day 1, 15 of cycle 4; PrD on Day 1 of cycle 7, 10,13,16,19,22,25, & 28 (Each cycle: 28 days)

The AUC(0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.

Outcome measures

Outcome measures
Measure	Part A Cohort 1: M9241 4 mcg/kg + Avelumab 10 mg/kg n=8 Participants Participants received M9241 at a dose of 4 micrograms per kilogram (mcg/kg) a subcutaneous (SC) injection at time (up to -20 minutes) relative to the start of Avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 2 weeks on Day 1 and 15 during each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 2: M9241 8 mcg/kg + Avelumab 10 mg/kg n=7 Participants Participants received M9241 at a dose of 8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 3: M9241 12 mcg/kg + Avelumab 10 mg/kg n=7 Participants Participants received M9241 at a dose of 12 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 4: M9241 16.8 mcg/kg +Avelumab 10 mg/kg n=6 Participants Participants received M9241 at a dose of 16.8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 5: M9241 16.8 mcg/kg + Avelumab 800 mg n=7 Participants Participants received M9241 at a dose of 16.8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 800 milligrams (mg) IV infusion once weekly for the first 12 weeks, then 800 mg once every 2 weeks of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.
Part A: Area Under Serum Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Avelumab Cycle 1 Day 1	22300 microgramhour per milliliter (mcgh/mL) Geometric Coefficient of Variation 41.5	30100 microgramhour per milliliter (mcgh/mL) Geometric Coefficient of Variation 75.8	26500 microgramhour per milliliter (mcgh/mL) Geometric Coefficient of Variation 21.5	18800 microgramhour per milliliter (mcgh/mL) Geometric Coefficient of Variation 29.5	27000 microgramhour per milliliter (mcgh/mL) Geometric Coefficient of Variation 65.0
Part A: Area Under Serum Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Avelumab Cycle 1 Day 15	26300 microgramhour per milliliter (mcgh/mL) Geometric Coefficient of Variation 37.2	29800 microgramhour per milliliter (mcgh/mL) Geometric Coefficient of Variation 35.7	27100 microgramhour per milliliter (mcgh/mL) Geometric Coefficient of Variation 34.5	23000 microgramhour per milliliter (mcgh/mL) Geometric Coefficient of Variation 26.0	—
Part A: Area Under Serum Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Avelumab Cycle 1 Day 22	—	—	—	—	43400 microgramhour per milliliter (mcgh/mL) Geometric Coefficient of Variation 56.1
Part A: Area Under Serum Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Avelumab Cycle 2 Day 1	29800 microgramhour per milliliter (mcgh/mL) Geometric Coefficient of Variation 18.4	33100 microgramhour per milliliter (mcgh/mL) Geometric Coefficient of Variation 48.4	24300 microgramhour per milliliter (mcgh/mL) Geometric Coefficient of Variation 30.6	24400 microgramhour per milliliter (mcgh/mL) Geometric Coefficient of Variation 13.3	35100 microgramhour per milliliter (mcgh/mL) Geometric Coefficient of Variation 40.3

SECONDARY outcome

Lambda(z) was determined from the terminal slope of the log-transformed serum concentration curve using linear regression method.

Outcome measures

Outcome measures
Measure	Part A Cohort 1: M9241 4 mcg/kg + Avelumab 10 mg/kg n=8 Participants Participants received M9241 at a dose of 4 micrograms per kilogram (mcg/kg) a subcutaneous (SC) injection at time (up to -20 minutes) relative to the start of Avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 2 weeks on Day 1 and 15 during each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 2: M9241 8 mcg/kg + Avelumab 10 mg/kg n=7 Participants Participants received M9241 at a dose of 8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 3: M9241 12 mcg/kg + Avelumab 10 mg/kg n=7 Participants Participants received M9241 at a dose of 12 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 4: M9241 16.8 mcg/kg +Avelumab 10 mg/kg n=6 Participants Participants received M9241 at a dose of 16.8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 5: M9241 16.8 mcg/kg + Avelumab 800 mg n=7 Participants Participants received M9241 at a dose of 16.8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 800 milligrams (mg) IV infusion once weekly for the first 12 weeks, then 800 mg once every 2 weeks of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.
Part A: Terminal Elimination Rate Constant (Lambdaz) of Avelumab Cycle 1 Day 1	0.00847 One per hour (1/hour) Geometric Coefficient of Variation 29.6	0.00729 One per hour (1/hour) Geometric Coefficient of Variation 48.5	0.00756 One per hour (1/hour) Geometric Coefficient of Variation 20.6	0.00790 One per hour (1/hour) Geometric Coefficient of Variation 14.4	0.00822 One per hour (1/hour) Geometric Coefficient of Variation 37.1
Part A: Terminal Elimination Rate Constant (Lambdaz) of Avelumab Cycle 1 Day 15	0.00780 One per hour (1/hour) Geometric Coefficient of Variation 31.6	0.00814 One per hour (1/hour) Geometric Coefficient of Variation 15.7	0.00780 One per hour (1/hour) Geometric Coefficient of Variation 31.4	0.00803 One per hour (1/hour) Geometric Coefficient of Variation 17.1	—
Part A: Terminal Elimination Rate Constant (Lambdaz) of Avelumab Cycle 1 Day 22	—	—	—	—	0.00620 One per hour (1/hour) Geometric Coefficient of Variation 34.3
Part A: Terminal Elimination Rate Constant (Lambdaz) of Avelumab Cycle 2 Day 1	0.00659 One per hour (1/hour) Geometric Coefficient of Variation 15.7	0.00714 One per hour (1/hour) Geometric Coefficient of Variation 39.8	0.00868 One per hour (1/hour) Geometric Coefficient of Variation 19.2	0.00830 One per hour (1/hour) Geometric Coefficient of Variation 16.4	0.00793 One per hour (1/hour) Geometric Coefficient of Variation 35.9

SECONDARY outcome

Cmax is the maximum observed serum concentration obtained directly from the concentration versus time curve.

Outcome measures

Outcome measures
Measure	Part A Cohort 1: M9241 4 mcg/kg + Avelumab 10 mg/kg n=8 Participants Participants received M9241 at a dose of 4 micrograms per kilogram (mcg/kg) a subcutaneous (SC) injection at time (up to -20 minutes) relative to the start of Avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 2 weeks on Day 1 and 15 during each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 2: M9241 8 mcg/kg + Avelumab 10 mg/kg n=7 Participants Participants received M9241 at a dose of 8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 3: M9241 12 mcg/kg + Avelumab 10 mg/kg n=7 Participants Participants received M9241 at a dose of 12 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 4: M9241 16.8 mcg/kg +Avelumab 10 mg/kg n=6 Participants Participants received M9241 at a dose of 16.8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 5: M9241 16.8 mcg/kg + Avelumab 800 mg n=7 Participants Participants received M9241 at a dose of 16.8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 800 milligrams (mg) IV infusion once weekly for the first 12 weeks, then 800 mg once every 2 weeks of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.
Part A: Maximum Observed Serum Concentration (Cmax) of Avelumab Cycle 1 Day 15	229 microgram/milliliter (mcg/mL) Geometric Coefficient of Variation 54.4	250 microgram/milliliter (mcg/mL) Geometric Coefficient of Variation 14.6	256 microgram/milliliter (mcg/mL) Geometric Coefficient of Variation 32.0	201 microgram/milliliter (mcg/mL) Geometric Coefficient of Variation 25.6	—
Part A: Maximum Observed Serum Concentration (Cmax) of Avelumab Cycle 1 Day 22	—	—	—	—	269 microgram/milliliter (mcg/mL) Geometric Coefficient of Variation 44.0
Part A: Maximum Observed Serum Concentration (Cmax) of Avelumab Cycle 2 Day 1	213 microgram/milliliter (mcg/mL) Geometric Coefficient of Variation 21.3	249 microgram/milliliter (mcg/mL) Geometric Coefficient of Variation 37.5	210 microgram/milliliter (mcg/mL) Geometric Coefficient of Variation 19.7	200 microgram/milliliter (mcg/mL) Geometric Coefficient of Variation 8.1	318 microgram/milliliter (mcg/mL) Geometric Coefficient of Variation 33.5
Part A: Maximum Observed Serum Concentration (Cmax) of Avelumab Cycle 1 Day 1	241 microgram/milliliter (mcg/mL) Geometric Coefficient of Variation 39.9	244 microgram/milliliter (mcg/mL) Geometric Coefficient of Variation 29.9	287 microgram/milliliter (mcg/mL) Geometric Coefficient of Variation 36.4	156 microgram/milliliter (mcg/mL) Geometric Coefficient of Variation 67.7	228 microgram/milliliter (mcg/mL) Geometric Coefficient of Variation 29.3
Part A: Maximum Observed Serum Concentration (Cmax) of Avelumab Cycle 4 Day 1	—	—	—	—	NA microgram/milliliter (mcg/mL) Geometric Coefficient of Variation NA Based on pre-specified criteria, statistical analysis for PK was only performed if more than 3 participants have reportable parameter values.

SECONDARY outcome

Cmin is minimum observed serum concentration obtained directly from the concentration versus time curve.

Outcome measures

Outcome measures
Measure	Part A Cohort 1: M9241 4 mcg/kg + Avelumab 10 mg/kg n=6 Participants Participants received M9241 at a dose of 4 micrograms per kilogram (mcg/kg) a subcutaneous (SC) injection at time (up to -20 minutes) relative to the start of Avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 2 weeks on Day 1 and 15 during each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 2: M9241 8 mcg/kg + Avelumab 10 mg/kg n=5 Participants Participants received M9241 at a dose of 8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 3: M9241 12 mcg/kg + Avelumab 10 mg/kg n=5 Participants Participants received M9241 at a dose of 12 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 4: M9241 16.8 mcg/kg +Avelumab 10 mg/kg n=6 Participants Participants received M9241 at a dose of 16.8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 5: M9241 16.8 mcg/kg + Avelumab 800 mg n=7 Participants Participants received M9241 at a dose of 16.8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 800 milligrams (mg) IV infusion once weekly for the first 12 weeks, then 800 mg once every 2 weeks of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.
Part A: Minimum Observed Serum Concentration (Cmin) of Avelumab Cycle 1 Day 15	11.3 mcg/mL Geometric Coefficient of Variation 90.4	14.5 mcg/mL Geometric Coefficient of Variation 37.2	14.0 mcg/mL Geometric Coefficient of Variation 70.3	9.28 mcg/mL Geometric Coefficient of Variation 51.8	—
Part A: Minimum Observed Serum Concentration (Cmin) of Avelumab Cycle 1 Day 22	—	—	—	—	74.1 mcg/mL Geometric Coefficient of Variation 62.0
Part A: Minimum Observed Serum Concentration (Cmin) of Avelumab Cycle 2 Day 1	20.5 mcg/mL Geometric Coefficient of Variation 37.6	24.0 mcg/mL Geometric Coefficient of Variation 79.9	14.4 mcg/mL Geometric Coefficient of Variation 91.9	13.1 mcg/mL Geometric Coefficient of Variation 24.4	59.3 mcg/mL Geometric Coefficient of Variation 122.5
Part A: Minimum Observed Serum Concentration (Cmin) of Avelumab Cycle 4 Day 1	—	—	—	—	NA mcg/mL Geometric Coefficient of Variation NA Based on pre-specified criteria, statistical analysis for PK was only performed if more than 3 participants have reportable parameter values.

SECONDARY outcome

Tmax is time to reach maximum observed serum concentration obtained directly from the concentration versus time curve.

Outcome measures

Outcome measures
Measure	Part A Cohort 1: M9241 4 mcg/kg + Avelumab 10 mg/kg n=8 Participants Participants received M9241 at a dose of 4 micrograms per kilogram (mcg/kg) a subcutaneous (SC) injection at time (up to -20 minutes) relative to the start of Avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 2 weeks on Day 1 and 15 during each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 2: M9241 8 mcg/kg + Avelumab 10 mg/kg n=7 Participants Participants received M9241 at a dose of 8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 3: M9241 12 mcg/kg + Avelumab 10 mg/kg n=7 Participants Participants received M9241 at a dose of 12 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 4: M9241 16.8 mcg/kg +Avelumab 10 mg/kg n=6 Participants Participants received M9241 at a dose of 16.8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 5: M9241 16.8 mcg/kg + Avelumab 800 mg n=7 Participants Participants received M9241 at a dose of 16.8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 800 milligrams (mg) IV infusion once weekly for the first 12 weeks, then 800 mg once every 2 weeks of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.
Part A: Time to Reach Maximum Observed Concentration (Tmax) of Avelumab Cycle 1 Day 1	4.00 hours Interval 1.0 to 25.08	1.05 hours Interval 1.0 to 9.0	3.90 hours Interval 1.0 to 4.25	2.58 hours Interval 1.0 to 44.78	4.00 hours Interval 1.0 to 22.2
Part A: Time to Reach Maximum Observed Concentration (Tmax) of Avelumab Cycle 2 Day 1	1.58 hours Interval 1.13 to 25.0	1.17 hours Interval 1.1 to 4.08	23.07 hours Interval 3.98 to 25.0	2.00 hours Interval 1.0 to 25.35	4.00 hours Interval 1.12 to 9.0
Part A: Time to Reach Maximum Observed Concentration (Tmax) of Avelumab Cycle 4 Day 1	—	—	—	—	NA hours Based on pre-specified criteria, statistical analysis for PK was only performed if more than 3 participants have reportable parameter values.
Part A: Time to Reach Maximum Observed Concentration (Tmax) of Avelumab Cycle 1 Day 15	5.04 hours Interval 1.0 to 48.42	1.13 hours Interval 1.0 to 25.72	4.00 hours Interval 1.22 to 49.0	4.09 hours Interval 1.03 to 29.18	—
Part A: Time to Reach Maximum Observed Concentration (Tmax) of Avelumab Cycle 1 Day 22	—	—	—	—	4.00 hours Interval 1.0 to 43.03

SECONDARY outcome

Apparent terminal half-life was defined as the time required for the serum concentration of drug to decrease 50 percent in the final stage of its elimination.

Outcome measures

Outcome measures
Measure	Part A Cohort 1: M9241 4 mcg/kg + Avelumab 10 mg/kg n=8 Participants Participants received M9241 at a dose of 4 micrograms per kilogram (mcg/kg) a subcutaneous (SC) injection at time (up to -20 minutes) relative to the start of Avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 2 weeks on Day 1 and 15 during each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 2: M9241 8 mcg/kg + Avelumab 10 mg/kg n=7 Participants Participants received M9241 at a dose of 8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 3: M9241 12 mcg/kg + Avelumab 10 mg/kg n=7 Participants Participants received M9241 at a dose of 12 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 4: M9241 16.8 mcg/kg +Avelumab 10 mg/kg n=6 Participants Participants received M9241 at a dose of 16.8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 5: M9241 16.8 mcg/kg + Avelumab 800 mg n=7 Participants Participants received M9241 at a dose of 16.8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 800 milligrams (mg) IV infusion once weekly for the first 12 weeks, then 800 mg once every 2 weeks of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.
Part A: Apparent Terminal Half-life (t1/2) of Avelumab Cycle 1 Day 1	94.7 hours Interval 48.4 to 108.0	87.4 hours Interval 50.2 to 223.0	95.2 hours Interval 70.1 to 123.0	87.1 hours Interval 69.4 to 106.0	70.5 hours Interval 60.2 to 148.0
Part A: Apparent Terminal Half-life (t1/2) of Avelumab Cycle 1 Day 15	101 hours Interval 54.9 to 115.0	77.6 hours Interval 75.0 to 103.0	84.1 hours Interval 65.0 to 136.0	86.7 hours Interval 69.9 to 106.0	—
Part A: Apparent Terminal Half-life (t1/2) of Avelumab Cycle 1 Day 22	—	—	—	—	102 hours Interval 83.3 to 180.0
Part A: Apparent Terminal Half-life (t1/2) of Avelumab Cycle 2 Day 1	106 hours Interval 88.5 to 125.0	94.9 hours Interval 68.6 to 173.0	80.7 hours Interval 67.5 to 95.1	86.2 hours Interval 67.0 to 98.1	81.1 hours Interval 55.9 to 138.0

SECONDARY outcome

AUCtau was defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).

Outcome measures

Outcome measures
Measure	Part A Cohort 1: M9241 4 mcg/kg + Avelumab 10 mg/kg n=8 Participants Participants received M9241 at a dose of 4 micrograms per kilogram (mcg/kg) a subcutaneous (SC) injection at time (up to -20 minutes) relative to the start of Avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 2 weeks on Day 1 and 15 during each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 2: M9241 8 mcg/kg + Avelumab 10 mg/kg n=7 Participants Participants received M9241 at a dose of 8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 3: M9241 12 mcg/kg + Avelumab 10 mg/kg n=7 Participants Participants received M9241 at a dose of 12 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 4: M9241 16.8 mcg/kg +Avelumab 10 mg/kg n=6 Participants Participants received M9241 at a dose of 16.8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 5: M9241 16.8 mcg/kg + Avelumab 800 mg n=7 Participants Participants received M9241 at a dose of 16.8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 800 milligrams (mg) IV infusion once weekly for the first 12 weeks, then 800 mg once every 2 weeks of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.
Part A: Area Under the Serum Concentration-Time Curve Within One Dosing Interval (AUC0-tau) of Avelumab Cycle 1 Day 1	20900 mcg*h/mL Geometric Coefficient of Variation 37.6	26700 mcg*h/mL Geometric Coefficient of Variation 58.3	24500 mcg*h/mL Geometric Coefficient of Variation 19.2	17400 mcg*h/mL Geometric Coefficient of Variation 33.1	19800 mcg*h/mL Geometric Coefficient of Variation 44.7
Part A: Area Under the Serum Concentration-Time Curve Within One Dosing Interval (AUC0-tau) of Avelumab Cycle 1 Day 15	24100 mcg*h/mL Geometric Coefficient of Variation 35.0	27600 mcg*h/mL Geometric Coefficient of Variation 33.1	28300 mcg*h/mL Geometric Coefficient of Variation 39.4	21400 mcg*h/mL Geometric Coefficient of Variation 24.2	—
Part A: Area Under the Serum Concentration-Time Curve Within One Dosing Interval (AUC0-tau) of Avelumab Cycle 1 Day 22	—	—	—	—	27500 mcg*h/mL Geometric Coefficient of Variation 34.7
Part A: Area Under the Serum Concentration-Time Curve Within One Dosing Interval (AUC0-tau) of Avelumab Cycle 2 Day 1	26400 mcg*h/mL Geometric Coefficient of Variation 17.4	29500 mcg*h/mL Geometric Coefficient of Variation 37.6	22900 mcg*h/mL Geometric Coefficient of Variation 27.1	22800 mcg*h/mL Geometric Coefficient of Variation 11.6	25500 mcg*h/mL Geometric Coefficient of Variation 26.1
Part A: Area Under the Serum Concentration-Time Curve Within One Dosing Interval (AUC0-tau) of Avelumab Cycle 4 Day 1	—	—	—	—	NA mcg*h/mL Geometric Coefficient of Variation NA Based on pre-specified criteria, statistical analysis for PK was only performed if more than 3 participants have reportable parameter values.

SECONDARY outcome

Timeframe: PrD, 1, 4, 8 hours PD on Day 1 of cycle 1 and Day 1 of cycle 2; PrD on Day 15 of cycle 1 and cycle 2; PrD, 1hour PD on Day 1 of cycle 3 and cycle 4; PrD on Day 1 Cycle 7, 10, 13, 16, 19, 22, 25, and 28 (Each cycle: 28 days)

Area under the serum concentration versus time curve from time zero to the last sampling time t at which the concentration is at or above the lower limit of quantification (LLLQ). (AUC0-t) was calculated according to the mixed log-linear trapezoidal rule.

Outcome measures

Outcome measures
Measure	Part A Cohort 1: M9241 4 mcg/kg + Avelumab 10 mg/kg n=5 Participants Participants received M9241 at a dose of 4 micrograms per kilogram (mcg/kg) a subcutaneous (SC) injection at time (up to -20 minutes) relative to the start of Avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 2 weeks on Day 1 and 15 during each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 2: M9241 8 mcg/kg + Avelumab 10 mg/kg n=7 Participants Participants received M9241 at a dose of 8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 3: M9241 12 mcg/kg + Avelumab 10 mg/kg n=6 Participants Participants received M9241 at a dose of 12 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 4: M9241 16.8 mcg/kg +Avelumab 10 mg/kg n=6 Participants Participants received M9241 at a dose of 16.8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 10 mg/kg IV infusion every 2 weeks on Day 1 and 15 of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.	Part A Cohort 5: M9241 16.8 mcg/kg + Avelumab 800 mg n=7 Participants Participants received M9241 at a dose of 16.8 mcg/kg SC injection at time (up to -20 minutes) relative to the start of avelumab infusion (time 0), once every 4 weeks, on Day 1 in combination with Avelumab 800 milligrams (mg) IV infusion once weekly for the first 12 weeks, then 800 mg once every 2 weeks of each cycle (Each cycle=28 days) until any criterion for treatment discontinuation were met.
Part A: Area Under Serum Concentration Time Curve From Time Zero to the Time of the Last Observation (AUC0-t) of M9241 Cycle 1 Day 1	105 nanogramhour/milliliter (ngh/mL) Geometric Coefficient of Variation 114.4	421 nanogramhour/milliliter (ngh/mL) Geometric Coefficient of Variation 82.9	661 nanogramhour/milliliter (ngh/mL) Geometric Coefficient of Variation 58.2	621 nanogramhour/milliliter (ngh/mL) Geometric Coefficient of Variation 96.5	873 nanogramhour/milliliter (ngh/mL) Geometric Coefficient of Variation 264.0
Part A: Area Under Serum Concentration Time Curve From Time Zero to the Time of the Last Observation (AUC0-t) of M9241 Cycle 2 Day 1	183 nanogramhour/milliliter (ngh/mL) Geometric Coefficient of Variation 151.7	306 nanogramhour/milliliter (ngh/mL) Geometric Coefficient of Variation 132.6	184 nanogramhour/milliliter (ngh/mL) Geometric Coefficient of Variation 174.0	1250 nanogramhour/milliliter (ngh/mL) Geometric Coefficient of Variation 46.2	1060 nanogramhour/milliliter (ngh/mL) Geometric Coefficient of Variation 308.8
Part A: Area Under Serum Concentration Time Curve From Time Zero to the Time of the Last Observation (AUC0-t) of M9241 Cycle 4 Day 1	—	—	—	—	NA nanogramhour/milliliter (ngh/mL) Geometric Coefficient of Variation NA Based on pre-specified criteria, statistical analysis for PK was only performed if more than 3 participants have reportable parameter values.

SECONDARY outcome

Population: Pharmacokinetic analysis set included participants who completed at least 1 administration of avelumab and/or M9241 and provided at least 1 sample with a measurable concentration. Here, "Overall Number of participants analyzed", signifies participants evaluable for this outcome measure and "Number analyzed" signifies participants evaluable at the specified time point. None of the participants were analyzed in Part A Cohort 1: M9241 4 mcg/kg + Avelumab 10 mg/kg arm at specified timepoints.

The AUC(0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.