Study to Assess Safety and Efficacy of the Second Mitochondrial-derived Activator of Caspases (SMAC) Mimetic Debio 1143

A Dose-optimization, Exploratory Phase Ib/II Study to Assess Safety and Efficacy of the Second Mitochondrial-derived Activator of Caspases (SMAC) Mimetic Debio 1143, When Given in Combination With the Anti-PD-1 Antibody Nivolumab in Patients With Specific Solid Tumors Who Have Progressed During or Immediately After Anti-PD-1/PD-L1 Treatment

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04122625

Acronym

SMARTPLUS-106

Enrollment

Registered

2019-10-10

Start date

2019-04-26

Completion date

2022-04-06

Last updated

2023-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumor

Brief summary

Part A (dose-optimization)- to determine the recommended phase 2 dose (RP2D) taking into account dose-limiting toxicity (DLT/s) in Cycle 1, overall safety/tolerability and pharmacokinetic (PK), by optimizing doses of Debio 1143 when combined with the standard dose of nivolumab, as well as treatment compliance in participants with advanced solid malignancies who failed prior systemic standard treatments. Part B (basket trial)- to evaluate the preliminary anti-tumor activity of Debio 1143 at the RP2D in combination with nivolumab at the standard dose, overall and in each participant cohort (Cohort 1: small cell lung cancer \[SCLC\]; Cohort 2: squamous cell carcinoma of the head and neck \[SCCHN\]; Cohort 3: gastrointestinal (GI) cancers with known microsatellite instability-high/mismatch repair deficiency (MSI-H/MMRd) or other deoxyribonucleic acid (DNA) damage repair (DDR) abnormalities, including homologous recombination deficiency (HRD); Cohort 4: platinum-resistant epithelial ovarian cancer \[EOC\], endometrial cancer, primary peritoneal cancer (PPC) or cervical cancer, with known MSIH/MMRd, hereditary/somatic mutations of the breast cancer 1 (BRCA1) and BRCA2 genes or other DNA DDR abnormalities (incl. HRD).

Interventions

DRUGDebio 1143

Administered as capsules.

DRUGNivolumab

Administered as IV infusion.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Have received at least one prior line of standard systemic chemotherapy in the advanced/unresectable cancer setting (standard adjuvant/neoadjuvant treatment is acceptable if relapse occurred within six months of treatment end) * Have progressed or relapsed during or after a prior anti-programmed cell death-1 (PD-1)/ programmed cell death-ligand 1 (PD-L1)-based treatment, given either as a single agent or in combination with standard/approved chemotherapy, tyrosine kinase inhibitors (TKIs), radiotherapy (RT) or other monoclonal antibodies (mAbs) that are not known to modulate/inhibit immune checkpoints (CPIs) * Measurable disease (Part B only) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or Gynecologic Cancer Intergroup (GCIG) criteria in Cohort #4 of Part B (if applicable) and documented PD during or after prior PD-1/PD-L1 based therapy

Exclusion criteria

* Thoracic or head and neck radiation \>30 gray (Gy) within the 3 months prior to Cycle 1 Day 1 (C1D1) * Have received, in total, more than 3 (i.e., Cohorts 1 & 2) or 4 (i.e., Cohorts 3 & 4) lines of prior systemic treatments in Part B (including adjuvant or neoadjuvant regimens if relapse within six months prior to C1D1) * Liver cirrhosis Child-Pugh score B or C

Design outcomes

Primary

Measure	Time frame	Description
Part A: Number of Participants With Dose-limiting Toxicities (DLTs)	Part A: Cycle 1 (28 days)	DLT: any of following treatment-emergent adverse events (TEAEs) as per NCI CTCAE Grade V5.0 Criteria (Grades 1=mild, 2=moderate, 3=severe and 4 or 5= life-threatening/fatal outcomes) which are possibly, probably or definitely related to combination treatment and occurring in Cycle 1 (1 Cycle=28 days): Any Grade 4 or 5 hematologic toxicity, clinical or laboratory non-hematologic toxicity; febrile neutropenia any grade, Grade 3 thrombocytopenia if associated with bleeding or requiring platelet transfusion; Grade 2; Grade 3 and any other Grade 3 non-hematologic, treatment-related clinical toxicity lasting ≥3 days; delay of \>2 weeks due to drug-related toxicity in initiating Cycle 2; unable to complete at least 70% of the scheduled treatment (\>six Debio 1143 skipped doses in Cycle 1) due to treatment-related toxicity; required dose reduction in Cycle 1 or on Cycle 2 Day 1 or requirement for treatment withdrawal due to treatment-related toxicity (even if not meeting other DLT criteria).
Part B: Confirmed Objective Response Rate (ORR)	Part B: From the start of study treatment until disease progression/recurrence was documented, a new systemic anti-cancer therapy was started or analysis cut-off, whichever occurred first (up to approximately 2.05 years)	ORR was determined per response evaluation criteria in solid tumors (RECIST) v1.1 and/or gynecologic cancer intergroup (GCIG) criteria (for Cohort 4). ORR was calculated as the percentage of participants with a confirmed objective response. A confirmed objective response is a confirmed best overall response of partial response (PR) or complete response (CR) recorded after the start of study treatment until disease progression/recurrence was documented, a new systemic anti-cancer therapy was started or analysis cut-off, whichever occurred first. CR is defined by the disappearance of all target lesions and reduction of any pathological lymph nodes in short axis to \<10 millimeters (mm). PR is defined by at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameter.

Secondary

Measure	Time frame	Description
Parts A and B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Including Laboratory Abnormalities Reported as TEAEs, and Serious Adverse Events (SAEs)	From the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B)	An adverse event (AE) is any untoward medical occurrence in a clinical trial participant administered a medicinal product that does not necessarily have a causal relationship with this treatment. A TEAE is any new, related or non-related, undesirable medical occurrence or change of an existing condition in a participant that occurs during the treatment-emergent period, starting or worsening on or after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy - 1 day, whichever occurs first. An SAE is defined as any untoward medical occurrence that at any dose results in death; is life-threatening (i.e., puts the participant at immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect, or is otherwise medically significant.
Parts A and B: Change From Baseline in Weight	From Baseline up to end of treatment (up to approximately 1.53 years in Part A and up to 1 year in Part B)	—
Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Vital Signs	From Baseline up to end of treatment (up to approximately 1.53 years in Part A and up to 1 year in Part B)	Vital sign parameters assessed comprise of systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate. Markedly abnormal criteria for vital signs include SBP \[millimeters of mercury (mmHg)\]: ≤ 90 mmHg OR change from baseline ≤ -20 mmHg, ≥ 140 mmHg OR change from baseline ≥ 20 mmHg; DBP (mmHg): ≤ 60 mmHg OR change from baseline ≤ -20 mmHg, ≥ 90 mmHg OR change from baseline ≥ 20 mmHg; Heart rate \[beats per minute (bpm)\]: ≤ 50 bpm OR change from baseline ≤ -20 bpm, ≥ 100 bpm OR change from baseline ≥ 20 bpm.
Parts A and B: Number of Participants With Change From Baseline in Temperature Reported as TEAEs	From Baseline up to end of treatment (up to approximately 1.53 years in Part A and up to 1 year in Part B)	Change from baseline in temperature reported as TEAEs included pyrexia. A TEAE is any new, related or non-related, undesirable medical occurrence or change of an existing condition in a participant that occurs during the treatment-emergent period, starting or worsening on or after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy - 1 day, whichever occurs first.
Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	From Baseline up to end of treatment (up to approximately 1.53 years in Part A and up to 1 year in Part B)	ECG parameters comprised of PR Interval \[millisecond (msec)\], QRS Interval (msec), QT Interval (msec), QTcB Interval (msec), QTcF Interval (msec), heart rate (HR) (bpm), RR interval (msec), derived HR (msec), calculated as 60000/RR interval \[for data checking only: should be within 5% of HR\]. Marked abnormal criteria for ECG parameters included absolute values QRS interval: \< 50 msec, \> 110 msec; absolute values for QT interval, QTcB interval: \>450 msec, \> 480 msec, \> 500 msec, QTcF: \> 480 msec, \> 500 msec; change from baseline values for QTcB interval, and QTcF: \>30 msec increase from baseline, \>60 msec increase from baseline. Data for highest on-treatment change from baseline as per the markedly abnormal criteria for ECG parameters are reported. On-treatment is the period of time between the first and last administration of any study drug. Participants with at least one markedly abnormal change from baseline value in the above categories are reported.
Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	From Baseline up to end of treatment (up to approximately 1.53 years in Part A and up to 1 year in Part B)	The ECOG-PS was used to assess the effect of disease progression on participants' daily activities. ECOG-PS is graded as follows: Grade 0 - fully active, able to carry on all pre-disease performance without restriction; Grade 1 - restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; Grade 2 - ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50% of waking hours; Grade 3 - capable of only limited self-care, confined to bed or chair for more than 50% of waking hours; Grade 4 - completely disabled, cannot carry on any self-care, totally confined to bed or chair; Grade 5 - dead. Shift values from baseline grade to worst on-treatment grade and missing values were reported.
Parts A and B: Number of Participants With TEAEs Including Laboratory Abnormalities Leading to Treatment Discontinuations and Dose Modifications	From the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B)	—
Part A: Confirmed Objective Response Rate (ORR)	Part A: From the start of study treatment until disease progression/recurrence was documented, a new systemic anti-cancer therapy was started or analysis cut-off, whichever occurred first (up to approximately 2.08 years)	ORR was determined per RECIST v1.1. ORR was calculated as the percentage of participants with a confirmed objective response. A confirmed objective response is a confirmed best overall response of PR or CR recorded after the start of study treatment until disease progression/recurrence was documented, a new systemic anti-cancer therapy was started or analysis cut-off, whichever occurred first. CR is defined by the disappearance of all target lesions and reduction of any pathological lymph nodes in short axis to \<10 mm. PR is defined by at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameter.
Parts A and B: Unconfirmed Objective Response Rate (uORR)	From the start of study treatment until disease progression/recurrence was documented, a new systemic anti-cancer therapy was started or analysis cut-off, whichever occurred first (up to approximately 2.08 years in Part A and 2.05 years in Part B)	uORR was calculated as the percentage of participants with unconfirmed objective response per RECIST v1.1. Unconfirmed objective response is an unconfirmed best overall response of PR or CR. Objective response was derived as any PR or CR recorded after the start of study treatment until disease progression/recurrence was documented, a new systemic anti-cancer therapy was started or analysis cut-off, whichever occurred first. CR is defined by the disappearance of all target lesions and reduction of any pathological lymph nodes in short axis to \<10 mm. PR is defined by at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameter.
Parts A and B: Disease Control Rate (DCR)	From the start of study treatment until disease progression/recurrence was documented, a new systemic anti-cancer therapy was started or analysis cut-off, whichever occurred first (up to approximately 2.08 years in Part A and 2.05 years in Part B)	DCR was calculated as the percentage of participants with disease control. Disease control was derived as any CR, PR, or stable disease reported during the study. CR is defined by the disappearance of all target lesions and reduction of any pathological lymph nodes in short axis to \<10 mm. PR is defined by at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameter.
Parts A and B: Median Duration of Response (DOR)	From the start of study treatment until disease progression/recurrence was documented, a new systemic anti-cancer therapy was started or analysis cut-off, whichever occurred first (up to approximately 2.08 years in Part A and 2.05 years in Part B)	DOR is defined as the time, in months, between date of the initial response (PR or CR) or date of first reduction of 50% in carbohydrate antigen 125 (CA-125), and date of the first documented disease progression or death due to any cause, whichever occurs first. CR is defined by the disappearance of all target lesions and reduction of any pathological lymph nodes in short axis to \<10 mm. PR is defined by at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameter. Data is reported as Kaplan-Meier product-limit estimates.
Parts A and B: Progression Free Survival (PFS)	From the start of study treatment until disease progression/recurrence or death from any cause, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B)	PFS duration is defined as the time, in months, elapsed between treatment initiation and tumor progression or death from any cause, whichever occurs first.
Parts A and B: PFS Rate at Months 6 and 12	Months 6 and 12	PFS is defined as duration elapsed between treatment initiation and tumor progression or death from any cause, whichever occurs first. Data for PFS rate is reported as Kaplan-Meier product-limit estimates and includes Brookmeyer-Crowley confidence intervals.
Parts A and B: Overall Survival (OS)	From the start of study treatment until death from any cause, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B)	OS is defined as the time elapsed, in months, between treatment initiation and death from any cause.
Parts A and B: OS Rate at Months 12 and 18	Months 12 and 18	OS is defined as the time elapsed, in months, between treatment initiation and death from any cause. Data for OS rate is reported as Kaplan-Meier product-limit estimates and includes Brookmeyer-Crowley confidence intervals.
Part A: Area Under the Curve From Time 0 to 4 Hours (AUC0-4H) of Debio 1143 and Debio 1143-MET1	Cycle 1: predose, 0.5, 1.5, 4 hours post-dose on Days 1 and 15, predose, 1.5, 4 hours post-dose on Days 8 and 22; Cycle 3: predose, 0.5, 1.5, 4 hours post-dose on Day 1 and predose, 1.5, 4 hours post-dose on Day 15 (each cycle=28 days)	—
Part B: AUC0-4H of Debio 1143 and Debio 1143-MET1	Cycle 1: predose, 1.5, 4 hours post-dose on Days 1 and 22; Cycle 3: predose, 1.5, 4 hours post-dose on Day 1 (each cycle = 28 days)	—
Part A: Area Under the Curve From Time 0 to 8 Hours (AUC0-8H) of Debio 1143 and Debio 1143-MET1	Cycle 1: predose, 0.5, 1.5, 4, 8 hours post-dose on Days 1 and 15, and predose, 1.5, 4, 8 hours post-dose on Day 8; Cycle 3: predose, 0.5, 1.5, 4, 8 hours post-dose on Day 1 and predose, 1.5, 4, 8 hours post-dose on Day 15 (each cycle = 28 days)	—
Part A: Maximum Observed Concentration (Cmax) of Debio 1143 and Debio 1143-MET1	Cycle 1: Predose,0.5,1.5,4,8 hours post-dose (Days 1 and 15), predose,1.5,4,8 hours post-dose (Day 8), predose,1.5,4 hours post-dose (Day 22); Cycle 3: predose,0.5,1.5,4,8 hours post-dose (Day 1), predose,1.5,4,8 hours post-dose (Day 15) (Cycle=28 days)	—
Part B: Cmax of Debio 1143 and Debio 1143-MET1	Cycle 1: predose, 1.5, 4 hours post-dose on Days 1 and 22; Cycle 3: predose, 1.5, 4 hours post-dose on Day 1 (each cycle = 28 days)	—
Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Cycle 1: predose on Days 3, 8, 15, 17 and 22; Cycle 3: predose on Days 1, 3, 15, 17; Cycle 6: predose on Day 1	—
Part B: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Cycle 1: predose on Days 8 and 22; Cycle 3: predose on Day 1 (each cycle = 28 days)	—
Part A: Serum Trough Concentration of Nivolumab	Cycle 1: predose, 1.5, 8 hours post-dose on Day 15; Cycle 3: predose, 0.5, 1.5, 8 hours post-dose on Day 1 and predose, 1.5 hours post-dose on Day 15 (each cycle = 28 days)	—
Part B: Serum Trough Concentration of Nivolumab	Cycle 1: predose, 1.5 hours post-dose on Day 15; Cycle 3: predose, 1.5 hours post-dose on Days 1 and Day 15; Cycle 6: predose on Day 1 (each cycle = 28 days)	—
Parts A and B: Time to Response (TTR)	From the start of study treatment until disease progression/recurrence was documented, a new systemic anti-cancer therapy was started or analysis cut-off, whichever occurred first (up to approximately 2.08 years in Part A and 2.05 years in Part B)	The average of the time taken in days for PR is reported. PR is defined by at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameter.

Countries

France, Spain, United States

Participant flow

Recruitment details

Participants took part at 24 investigational sites in the United States, Spain, and France from 26 April 2019 to 6 April 2022.

Pre-assignment details

A total of 46 participants were enrolled in this study, 11 participants with advanced solid malignancies who failed prior systemic standard treatments into Part A and 35 participants into Part B of the study. Part B of the study was started after recommended phase 2 dose (RP2D) was determined in Part A and did not include any participants from Part A.

Participants by arm

Arm	Count
Part A - Debio 1143 150 mg + Nivolumab Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	3
Part A - Debio 1143 200 mg + Nivolumab Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	8
Part B - Cohort 1 (SCLC): Debio 1143 200 mg + Nivolumab Participants with SCLC received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	8
Part B - Cohort 2 (SCCHN): Debio 1143 200 mg + Nivolumab Participants with SCCHN received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	8
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	8
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	11
Total	46

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005
Part A (up to 2.92 Years)	Death	2	4	0	0	0	0
Part B (up to 2.33 Years)	Death	0	0	5	7	6	7
Part B (up to 2.33 Years)	Patient lost to follow-up	0	0	1	1	2	0

Baseline characteristics

Characteristic	Part A - Debio 1143 150 mg + Nivolumab	Total	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Part B - Cohort 2 (SCCHN): Debio 1143 200 mg + Nivolumab	Part B - Cohort 1 (SCLC): Debio 1143 200 mg + Nivolumab	Part A - Debio 1143 200 mg + Nivolumab
Age, Continuous	71.0 years	63.0 years	64.8 years	63.9 years	61.6 years	65.5 years	55.5 years
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants	34 Participants	6 Participants	7 Participants	6 Participants	5 Participants	7 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	11 Participants	5 Participants	1 Participants	2 Participants	2 Participants	1 Participants
Race/Ethnicity, Customized Race Other	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Race Unknown	0 Participants	11 Participants	5 Participants	1 Participants	2 Participants	2 Participants	1 Participants
Race/Ethnicity, Customized Race White	3 Participants	34 Participants	6 Participants	7 Participants	5 Participants	6 Participants	7 Participants
Sex: Female, Male Female	1 Participants	21 Participants	11 Participants	3 Participants	1 Participants	4 Participants	1 Participants
Sex: Female, Male Male	2 Participants	25 Participants	0 Participants	5 Participants	7 Participants	4 Participants	7 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk
deaths Total, all-cause mortality	2 / 3	4 / 8	5 / 8	7 / 8	6 / 8	7 / 11
other Total, other adverse events	3 / 3	8 / 8	8 / 8	8 / 8	8 / 8	11 / 11
serious Total, serious adverse events	0 / 3	8 / 8	0 / 8	6 / 8	5 / 8	5 / 11

Outcome results

Primary

Part A: Number of Participants With Dose-limiting Toxicities (DLTs)

DLT: any of following treatment-emergent adverse events (TEAEs) as per NCI CTCAE Grade V5.0 Criteria (Grades 1=mild, 2=moderate, 3=severe and 4 or 5= life-threatening/fatal outcomes) which are possibly, probably or definitely related to combination treatment and occurring in Cycle 1 (1 Cycle=28 days): Any Grade 4 or 5 hematologic toxicity, clinical or laboratory non-hematologic toxicity; febrile neutropenia any grade, Grade 3 thrombocytopenia if associated with bleeding or requiring platelet transfusion; Grade 2; Grade 3 and any other Grade 3 non-hematologic, treatment-related clinical toxicity lasting ≥3 days; delay of \>2 weeks due to drug-related toxicity in initiating Cycle 2; unable to complete at least 70% of the scheduled treatment (\>six Debio 1143 skipped doses in Cycle 1) due to treatment-related toxicity; required dose reduction in Cycle 1 or on Cycle 2 Day 1 or requirement for treatment withdrawal due to treatment-related toxicity (even if not meeting other DLT criteria).

Time frame: Part A: Cycle 1 (28 days)

Population: Recommended phase 2 dose (RP2D) population included participants who received at least 70% of Debio 1143 (i.e., a maximum of 6 missed Debio 1143 doses) and at least one nivolumab dose as planned in Cycle 1.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Part A - Debio 1143 150 mg + Nivolumab	Part A: Number of Participants With Dose-limiting Toxicities (DLTs)	0 Participants
Part A - Debio 1143 200 mg + Nivolumab	Part A: Number of Participants With Dose-limiting Toxicities (DLTs)	0 Participants

Primary

Part B: Confirmed Objective Response Rate (ORR)

ORR was determined per response evaluation criteria in solid tumors (RECIST) v1.1 and/or gynecologic cancer intergroup (GCIG) criteria (for Cohort 4). ORR was calculated as the percentage of participants with a confirmed objective response. A confirmed objective response is a confirmed best overall response of partial response (PR) or complete response (CR) recorded after the start of study treatment until disease progression/recurrence was documented, a new systemic anti-cancer therapy was started or analysis cut-off, whichever occurred first. CR is defined by the disappearance of all target lesions and reduction of any pathological lymph nodes in short axis to \<10 millimeters (mm). PR is defined by at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameter.

Time frame: Part B: From the start of study treatment until disease progression/recurrence was documented, a new systemic anti-cancer therapy was started or analysis cut-off, whichever occurred first (up to approximately 2.05 years)

Population: Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.

Arm	Measure	Value (NUMBER)
Part A - Debio 1143 150 mg + Nivolumab	Part B: Confirmed Objective Response Rate (ORR)	0.0 percentage of participants
Part A - Debio 1143 200 mg + Nivolumab	Part B: Confirmed Objective Response Rate (ORR)	0.0 percentage of participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Part B: Confirmed Objective Response Rate (ORR)	0.0 percentage of participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Part B: Confirmed Objective Response Rate (ORR)	9.1 percentage of participants

Secondary

Part A: Area Under the Curve From Time 0 to 4 Hours (AUC0-4H) of Debio 1143 and Debio 1143-MET1

Time frame: Cycle 1: predose, 0.5, 1.5, 4 hours post-dose on Days 1 and 15, predose, 1.5, 4 hours post-dose on Days 8 and 22; Cycle 3: predose, 0.5, 1.5, 4 hours post-dose on Day 1 and predose, 1.5, 4 hours post-dose on Day 15 (each cycle=28 days)

Population: Safety analysis set included all participants who were enrolled and received at least one dose of any study drug. Number analyzed indicates the number of participants with available data for analysis at the given timepoint.

Arm	Measure	Group	Value (MEAN)	Dispersion
Part A - Debio 1143 150 mg + Nivolumab	Part A: Area Under the Curve From Time 0 to 4 Hours (AUC0-4H) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 1	6200.28 hoursnanograms per milliliter (hng/mL)	Standard Deviation 330.246
Part A - Debio 1143 150 mg + Nivolumab	Part A: Area Under the Curve From Time 0 to 4 Hours (AUC0-4H) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 8	4321.40 hoursnanograms per milliliter (hng/mL)	Standard Deviation 1127.611
Part A - Debio 1143 150 mg + Nivolumab	Part A: Area Under the Curve From Time 0 to 4 Hours (AUC0-4H) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 15	5081.21 hoursnanograms per milliliter (hng/mL)	Standard Deviation 868.905
Part A - Debio 1143 150 mg + Nivolumab	Part A: Area Under the Curve From Time 0 to 4 Hours (AUC0-4H) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 22	4517.00 hoursnanograms per milliliter (hng/mL)	Standard Deviation 3539.938
Part A - Debio 1143 150 mg + Nivolumab	Part A: Area Under the Curve From Time 0 to 4 Hours (AUC0-4H) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 3 Day 1	4053.97 hoursnanograms per milliliter (hng/mL)	Standard Deviation 3005.43
Part A - Debio 1143 150 mg + Nivolumab	Part A: Area Under the Curve From Time 0 to 4 Hours (AUC0-4H) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 3 Day 15	4725.37 hoursnanograms per milliliter (hng/mL)	Standard Deviation 2033.252
Part A - Debio 1143 150 mg + Nivolumab	Part A: Area Under the Curve From Time 0 to 4 Hours (AUC0-4H) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 1	2624.48 hoursnanograms per milliliter (hng/mL)	Standard Deviation 953.275
Part A - Debio 1143 150 mg + Nivolumab	Part A: Area Under the Curve From Time 0 to 4 Hours (AUC0-4H) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 8	3884.59 hoursnanograms per milliliter (hng/mL)	Standard Deviation 565.589
Part A - Debio 1143 150 mg + Nivolumab	Part A: Area Under the Curve From Time 0 to 4 Hours (AUC0-4H) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 15	2104.06 hoursnanograms per milliliter (hng/mL)	Standard Deviation 325.456
Part A - Debio 1143 150 mg + Nivolumab	Part A: Area Under the Curve From Time 0 to 4 Hours (AUC0-4H) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 22	3634.33 hoursnanograms per milliliter (hng/mL)	Standard Deviation 1591.77
Part A - Debio 1143 150 mg + Nivolumab	Part A: Area Under the Curve From Time 0 to 4 Hours (AUC0-4H) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 3 Day 1	983.62 hoursnanograms per milliliter (hng/mL)	Standard Deviation 501.515
Part A - Debio 1143 150 mg + Nivolumab	Part A: Area Under the Curve From Time 0 to 4 Hours (AUC0-4H) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 3 Day 15	3255.14 hoursnanograms per milliliter (hng/mL)	Standard Deviation 513.699
Part A - Debio 1143 200 mg + Nivolumab	Part A: Area Under the Curve From Time 0 to 4 Hours (AUC0-4H) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 3 Day 1	2617.59 hoursnanograms per milliliter (hng/mL)	Standard Deviation 2250.993
Part A - Debio 1143 200 mg + Nivolumab	Part A: Area Under the Curve From Time 0 to 4 Hours (AUC0-4H) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 1	4907.15 hoursnanograms per milliliter (hng/mL)	Standard Deviation 2496.914
Part A - Debio 1143 200 mg + Nivolumab	Part A: Area Under the Curve From Time 0 to 4 Hours (AUC0-4H) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 1	1662.25 hoursnanograms per milliliter (hng/mL)	Standard Deviation 957.856
Part A - Debio 1143 200 mg + Nivolumab	Part A: Area Under the Curve From Time 0 to 4 Hours (AUC0-4H) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 8	5861.53 hoursnanograms per milliliter (hng/mL)	Standard Deviation 3764.659
Part A - Debio 1143 200 mg + Nivolumab	Part A: Area Under the Curve From Time 0 to 4 Hours (AUC0-4H) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 22	5064.61 hoursnanograms per milliliter (hng/mL)	Standard Deviation 4242.17
Part A - Debio 1143 200 mg + Nivolumab	Part A: Area Under the Curve From Time 0 to 4 Hours (AUC0-4H) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 15	5114.03 hoursnanograms per milliliter (hng/mL)	Standard Deviation 3168.408
Part A - Debio 1143 200 mg + Nivolumab	Part A: Area Under the Curve From Time 0 to 4 Hours (AUC0-4H) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 8	5133.24 hoursnanograms per milliliter (hng/mL)	Standard Deviation 3794.465
Part A - Debio 1143 200 mg + Nivolumab	Part A: Area Under the Curve From Time 0 to 4 Hours (AUC0-4H) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 22	4086.09 hoursnanograms per milliliter (hng/mL)	Standard Deviation 2516.921
Part A - Debio 1143 200 mg + Nivolumab	Part A: Area Under the Curve From Time 0 to 4 Hours (AUC0-4H) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 3 Day 15	2208.80 hoursnanograms per milliliter (hng/mL)	Standard Deviation 775.572
Part A - Debio 1143 200 mg + Nivolumab	Part A: Area Under the Curve From Time 0 to 4 Hours (AUC0-4H) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 3 Day 1	6844.02 hoursnanograms per milliliter (hng/mL)	Standard Deviation 4940.667
Part A - Debio 1143 200 mg + Nivolumab	Part A: Area Under the Curve From Time 0 to 4 Hours (AUC0-4H) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 15	1673.48 hoursnanograms per milliliter (hng/mL)	Standard Deviation 986.138
Part A - Debio 1143 200 mg + Nivolumab	Part A: Area Under the Curve From Time 0 to 4 Hours (AUC0-4H) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 3 Day 15	5934.72 hoursnanograms per milliliter (hng/mL)	Standard Deviation 2251.52

Secondary

Part A: Area Under the Curve From Time 0 to 8 Hours (AUC0-8H) of Debio 1143 and Debio 1143-MET1

Time frame: Cycle 1: predose, 0.5, 1.5, 4, 8 hours post-dose on Days 1 and 15, and predose, 1.5, 4, 8 hours post-dose on Day 8; Cycle 3: predose, 0.5, 1.5, 4, 8 hours post-dose on Day 1 and predose, 1.5, 4, 8 hours post-dose on Day 15 (each cycle = 28 days)

Population: Safety analysis set included all participants who were enrolled and received at least one dose of any study drug. Overall number of participants analyzed indicates number of participants available for analysis. Number analyzed indicates the number of participants with available data for analysis at the given timepoint.

Arm	Measure	Group	Value (MEAN)	Dispersion
Part A - Debio 1143 150 mg + Nivolumab	Part A: Area Under the Curve From Time 0 to 8 Hours (AUC0-8H) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 1	8954.45 h*ng/mL	Standard Deviation 1347.64
Part A - Debio 1143 150 mg + Nivolumab	Part A: Area Under the Curve From Time 0 to 8 Hours (AUC0-8H) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 8	6699.18 h*ng/mL	Standard Deviation 1315.19
Part A - Debio 1143 150 mg + Nivolumab	Part A: Area Under the Curve From Time 0 to 8 Hours (AUC0-8H) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 15	7280.65 h*ng/mL	Standard Deviation 945.078
Part A - Debio 1143 150 mg + Nivolumab	Part A: Area Under the Curve From Time 0 to 8 Hours (AUC0-8H) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 3 Day 1	4623.23 h*ng/mL	Standard Deviation 2089.994
Part A - Debio 1143 150 mg + Nivolumab	Part A: Area Under the Curve From Time 0 to 8 Hours (AUC0-8H) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 3 Day 15	6864.95 h*ng/mL	Standard Deviation 1815.779
Part A - Debio 1143 150 mg + Nivolumab	Part A: Area Under the Curve From Time 0 to 8 Hours (AUC0-8H) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 1	5940.42 h*ng/mL	Standard Deviation 2217.5
Part A - Debio 1143 150 mg + Nivolumab	Part A: Area Under the Curve From Time 0 to 8 Hours (AUC0-8H) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 8	7743.38 h*ng/mL	Standard Deviation 1258.029
Part A - Debio 1143 150 mg + Nivolumab	Part A: Area Under the Curve From Time 0 to 8 Hours (AUC0-8H) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 15	4921.26 h*ng/mL	Standard Deviation 741.691
Part A - Debio 1143 150 mg + Nivolumab	Part A: Area Under the Curve From Time 0 to 8 Hours (AUC0-8H) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 3 Day 1	2315.46 h*ng/mL	Standard Deviation 1568.487
Part A - Debio 1143 150 mg + Nivolumab	Part A: Area Under the Curve From Time 0 to 8 Hours (AUC0-8H) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 3 Day 15	6011.84 h*ng/mL	Standard Deviation 429.313
Part A - Debio 1143 200 mg + Nivolumab	Part A: Area Under the Curve From Time 0 to 8 Hours (AUC0-8H) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 15	4304.95 h*ng/mL	Standard Deviation 2105.077
Part A - Debio 1143 200 mg + Nivolumab	Part A: Area Under the Curve From Time 0 to 8 Hours (AUC0-8H) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 1	8497.84 h*ng/mL	Standard Deviation 3213.996
Part A - Debio 1143 200 mg + Nivolumab	Part A: Area Under the Curve From Time 0 to 8 Hours (AUC0-8H) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 1	5128.38 h*ng/mL	Standard Deviation 2307.49
Part A - Debio 1143 200 mg + Nivolumab	Part A: Area Under the Curve From Time 0 to 8 Hours (AUC0-8H) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 8	9437.55 h*ng/mL	Standard Deviation 6036.801
Part A - Debio 1143 200 mg + Nivolumab	Part A: Area Under the Curve From Time 0 to 8 Hours (AUC0-8H) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 3 Day 15	6225.18 h*ng/mL	Standard Deviation 2315.768
Part A - Debio 1143 200 mg + Nivolumab	Part A: Area Under the Curve From Time 0 to 8 Hours (AUC0-8H) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 15	8024.00 h*ng/mL	Standard Deviation 5036.125
Part A - Debio 1143 200 mg + Nivolumab	Part A: Area Under the Curve From Time 0 to 8 Hours (AUC0-8H) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 8	10646.90 h*ng/mL	Standard Deviation 8177.45
Part A - Debio 1143 200 mg + Nivolumab	Part A: Area Under the Curve From Time 0 to 8 Hours (AUC0-8H) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 3 Day 1	10627.09 h*ng/mL	Standard Deviation 6520.082
Part A - Debio 1143 200 mg + Nivolumab	Part A: Area Under the Curve From Time 0 to 8 Hours (AUC0-8H) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 3 Day 1	6632.52 h*ng/mL	Standard Deviation 6610.503
Part A - Debio 1143 200 mg + Nivolumab	Part A: Area Under the Curve From Time 0 to 8 Hours (AUC0-8H) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 3 Day 15	9072.05 h*ng/mL	Standard Deviation 3529.268

Secondary

Part A: Confirmed Objective Response Rate (ORR)

ORR was determined per RECIST v1.1. ORR was calculated as the percentage of participants with a confirmed objective response. A confirmed objective response is a confirmed best overall response of PR or CR recorded after the start of study treatment until disease progression/recurrence was documented, a new systemic anti-cancer therapy was started or analysis cut-off, whichever occurred first. CR is defined by the disappearance of all target lesions and reduction of any pathological lymph nodes in short axis to \<10 mm. PR is defined by at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameter.

Time frame: Part A: From the start of study treatment until disease progression/recurrence was documented, a new systemic anti-cancer therapy was started or analysis cut-off, whichever occurred first (up to approximately 2.08 years)

Population: Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.

Arm	Measure	Value (NUMBER)
Part A - Debio 1143 150 mg + Nivolumab	Part A: Confirmed Objective Response Rate (ORR)	0.0 percentage of participants
Part A - Debio 1143 200 mg + Nivolumab	Part A: Confirmed Objective Response Rate (ORR)	12.5 percentage of participants

Secondary

Part A: Maximum Observed Concentration (Cmax) of Debio 1143 and Debio 1143-MET1

Time frame: Cycle 1: Predose,0.5,1.5,4,8 hours post-dose (Days 1 and 15), predose,1.5,4,8 hours post-dose (Day 8), predose,1.5,4 hours post-dose (Day 22); Cycle 3: predose,0.5,1.5,4,8 hours post-dose (Day 1), predose,1.5,4,8 hours post-dose (Day 15) (Cycle=28 days)

Arm	Measure	Group	Value (MEAN)	Dispersion
Part A - Debio 1143 150 mg + Nivolumab	Part A: Maximum Observed Concentration (Cmax) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 1	3063.33 nanograms per milliliter (ng/mL)	Standard Deviation 771.838
Part A - Debio 1143 150 mg + Nivolumab	Part A: Maximum Observed Concentration (Cmax) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 8	1656.67 nanograms per milliliter (ng/mL)	Standard Deviation 568.624
Part A - Debio 1143 150 mg + Nivolumab	Part A: Maximum Observed Concentration (Cmax) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 15	2426.67 nanograms per milliliter (ng/mL)	Standard Deviation 567.656
Part A - Debio 1143 150 mg + Nivolumab	Part A: Maximum Observed Concentration (Cmax) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 22	2037.00 nanograms per milliliter (ng/mL)	Standard Deviation 1637.415
Part A - Debio 1143 150 mg + Nivolumab	Part A: Maximum Observed Concentration (Cmax) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 3 Day 1	1954.00 nanograms per milliliter (ng/mL)	Standard Deviation 1119.459
Part A - Debio 1143 150 mg + Nivolumab	Part A: Maximum Observed Concentration (Cmax) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 3 Day 15	1970.00 nanograms per milliliter (ng/mL)	Standard Deviation 1244.508
Part A - Debio 1143 150 mg + Nivolumab	Part A: Maximum Observed Concentration (Cmax) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 1	989.67 nanograms per milliliter (ng/mL)	Standard Deviation 344.515
Part A - Debio 1143 150 mg + Nivolumab	Part A: Maximum Observed Concentration (Cmax) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 8	1193.33 nanograms per milliliter (ng/mL)	Standard Deviation 222.336
Part A - Debio 1143 150 mg + Nivolumab	Part A: Maximum Observed Concentration (Cmax) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 15	868.00 nanograms per milliliter (ng/mL)	Standard Deviation 117.051
Part A - Debio 1143 150 mg + Nivolumab	Part A: Maximum Observed Concentration (Cmax) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 22	1088.33 nanograms per milliliter (ng/mL)	Standard Deviation 581.758
Part A - Debio 1143 150 mg + Nivolumab	Part A: Maximum Observed Concentration (Cmax) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 3 Day 1	611.00 nanograms per milliliter (ng/mL)	Standard Deviation 376.227
Part A - Debio 1143 150 mg + Nivolumab	Part A: Maximum Observed Concentration (Cmax) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 3 Day 15	1177.00 nanograms per milliliter (ng/mL)	Standard Deviation 272.943
Part A - Debio 1143 200 mg + Nivolumab	Part A: Maximum Observed Concentration (Cmax) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 3 Day 1	1343.60 nanograms per milliliter (ng/mL)	Standard Deviation 1078.4
Part A - Debio 1143 200 mg + Nivolumab	Part A: Maximum Observed Concentration (Cmax) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 1	2020.63 nanograms per milliliter (ng/mL)	Standard Deviation 1015.945
Part A - Debio 1143 200 mg + Nivolumab	Part A: Maximum Observed Concentration (Cmax) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 1	972.50 nanograms per milliliter (ng/mL)	Standard Deviation 489.14
Part A - Debio 1143 200 mg + Nivolumab	Part A: Maximum Observed Concentration (Cmax) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 8	2132.71 nanograms per milliliter (ng/mL)	Standard Deviation 1346.859
Part A - Debio 1143 200 mg + Nivolumab	Part A: Maximum Observed Concentration (Cmax) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 22	1658.68 nanograms per milliliter (ng/mL)	Standard Deviation 1339.093
Part A - Debio 1143 200 mg + Nivolumab	Part A: Maximum Observed Concentration (Cmax) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 15	1956.29 nanograms per milliliter (ng/mL)	Standard Deviation 1137.771
Part A - Debio 1143 200 mg + Nivolumab	Part A: Maximum Observed Concentration (Cmax) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 8	1733.23 nanograms per milliliter (ng/mL)	Standard Deviation 1184.636
Part A - Debio 1143 200 mg + Nivolumab	Part A: Maximum Observed Concentration (Cmax) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 22	1528.96 nanograms per milliliter (ng/mL)	Standard Deviation 910.236
Part A - Debio 1143 200 mg + Nivolumab	Part A: Maximum Observed Concentration (Cmax) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 3 Day 15	1148.50 nanograms per milliliter (ng/mL)	Standard Deviation 458.398
Part A - Debio 1143 200 mg + Nivolumab	Part A: Maximum Observed Concentration (Cmax) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 3 Day 1	3071.00 nanograms per milliliter (ng/mL)	Standard Deviation 1928.848
Part A - Debio 1143 200 mg + Nivolumab	Part A: Maximum Observed Concentration (Cmax) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 15	915.86 nanograms per milliliter (ng/mL)	Standard Deviation 390.84
Part A - Debio 1143 200 mg + Nivolumab	Part A: Maximum Observed Concentration (Cmax) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 3 Day 15	2265.00 nanograms per milliliter (ng/mL)	Standard Deviation 886.397

Secondary

Part A: Serum Trough Concentration of Nivolumab

Time frame: Cycle 1: predose, 1.5, 8 hours post-dose on Day 15; Cycle 3: predose, 0.5, 1.5, 8 hours post-dose on Day 1 and predose, 1.5 hours post-dose on Day 15 (each cycle = 28 days)

Arm	Measure	Group	Value (MEAN)	Dispersion
Part A - Debio 1143 150 mg + Nivolumab	Part A: Serum Trough Concentration of Nivolumab	Cycle 1 Day 15	21366.67 ng/mL	Standard Deviation 4808.673
Part A - Debio 1143 150 mg + Nivolumab	Part A: Serum Trough Concentration of Nivolumab	Cycle 3 Day 1	43500.00 ng/mL	—
Part A - Debio 1143 200 mg + Nivolumab	Part A: Serum Trough Concentration of Nivolumab	Cycle 1 Day 15	22271.43 ng/mL	Standard Deviation 7553.744
Part A - Debio 1143 200 mg + Nivolumab	Part A: Serum Trough Concentration of Nivolumab	Cycle 3 Day 1	32700.00 ng/mL	—
Part A - Debio 1143 200 mg + Nivolumab	Part A: Serum Trough Concentration of Nivolumab	Cycle 3 Day 15	27100.00 ng/mL	—

Secondary

Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1

Time frame: Cycle 1: predose on Days 3, 8, 15, 17 and 22; Cycle 3: predose on Days 1, 3, 15, 17; Cycle 6: predose on Day 1

Arm	Measure	Group	Value (MEAN)	Dispersion
Part A - Debio 1143 150 mg + Nivolumab	Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 3	113.10 ng/mL	Standard Deviation 31.892
Part A - Debio 1143 150 mg + Nivolumab	Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 8	118.27 ng/mL	Standard Deviation 30.751
Part A - Debio 1143 150 mg + Nivolumab	Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 15	7.34 ng/mL	—
Part A - Debio 1143 150 mg + Nivolumab	Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 17	99.37 ng/mL	Standard Deviation 19.29
Part A - Debio 1143 150 mg + Nivolumab	Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 22	83.53 ng/mL	Standard Deviation 19.63
Part A - Debio 1143 150 mg + Nivolumab	Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 3 Day 1	10.20 ng/mL	—
Part A - Debio 1143 150 mg + Nivolumab	Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 3 Day 3	110.47 ng/mL	Standard Deviation 13.808
Part A - Debio 1143 150 mg + Nivolumab	Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 3 Day 17	118.00 ng/mL	Standard Deviation 16.971
Part A - Debio 1143 150 mg + Nivolumab	Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 3	453.33 ng/mL	Standard Deviation 180.059
Part A - Debio 1143 150 mg + Nivolumab	Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 8	387.00 ng/mL	Standard Deviation 145.812
Part A - Debio 1143 150 mg + Nivolumab	Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 15	33.30 ng/mL	—
Part A - Debio 1143 150 mg + Nivolumab	Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 17	543.00 ng/mL	Standard Deviation 154.182
Part A - Debio 1143 150 mg + Nivolumab	Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 22	367.33 ng/mL	Standard Deviation 289.588
Part A - Debio 1143 150 mg + Nivolumab	Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 3 Day 1	6.97 ng/mL	—
Part A - Debio 1143 150 mg + Nivolumab	Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 3 Day 3	443.67 ng/mL	Standard Deviation 172.631
Part A - Debio 1143 150 mg + Nivolumab	Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 3 Day 17	611.00 ng/mL	Standard Deviation 322.441
Part A - Debio 1143 200 mg + Nivolumab	Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 3 Day 17	136.37 ng/mL	Standard Deviation 81.772
Part A - Debio 1143 200 mg + Nivolumab	Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 6 Day 1	5.31 ng/mL	—
Part A - Debio 1143 200 mg + Nivolumab	Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 6 Day 1	3.15 ng/mL	—
Part A - Debio 1143 200 mg + Nivolumab	Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 3	620.10 ng/mL	Standard Deviation 434.376
Part A - Debio 1143 200 mg + Nivolumab	Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 3 Day 1	23.65 ng/mL	Standard Deviation 27.655
Part A - Debio 1143 200 mg + Nivolumab	Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 3	169.50 ng/mL	Standard Deviation 120.014
Part A - Debio 1143 200 mg + Nivolumab	Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 8	793.65 ng/mL	Standard Deviation 953.516
Part A - Debio 1143 200 mg + Nivolumab	Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 8	173.35 ng/mL	Standard Deviation 113.797
Part A - Debio 1143 200 mg + Nivolumab	Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 3 Day 17	639.67 ng/mL	Standard Deviation 387.727
Part A - Debio 1143 200 mg + Nivolumab	Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 15	5.22 ng/mL	Standard Deviation 2.844
Part A - Debio 1143 200 mg + Nivolumab	Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 15	6.39 ng/mL	Standard Deviation 3.241
Part A - Debio 1143 200 mg + Nivolumab	Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 17	133.57 ng/mL	Standard Deviation 86.239
Part A - Debio 1143 200 mg + Nivolumab	Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 3 Day 3	1157.50 ng/mL	Standard Deviation 1304.612
Part A - Debio 1143 200 mg + Nivolumab	Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 22	173.70 ng/mL	Standard Deviation 135.079
Part A - Debio 1143 200 mg + Nivolumab	Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 17	531.93 ng/mL	Standard Deviation 560.633
Part A - Debio 1143 200 mg + Nivolumab	Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 3 Day 1	4.72 ng/mL	Standard Deviation 0.41
Part A - Debio 1143 200 mg + Nivolumab	Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 3 Day 15	13.55 ng/mL	Standard Deviation 9.687
Part A - Debio 1143 200 mg + Nivolumab	Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 3 Day 3	97.20 ng/mL	Standard Deviation 37.901
Part A - Debio 1143 200 mg + Nivolumab	Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 3 Day 15	8.71 ng/mL	Standard Deviation 6.64
Part A - Debio 1143 200 mg + Nivolumab	Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 22	805.78 ng/mL	Standard Deviation 961.228

Secondary

Part B: AUC0-4H of Debio 1143 and Debio 1143-MET1

Time frame: Cycle 1: predose, 1.5, 4 hours post-dose on Days 1 and 22; Cycle 3: predose, 1.5, 4 hours post-dose on Day 1 (each cycle = 28 days)

Arm	Measure	Group	Value (MEAN)	Dispersion
Part A - Debio 1143 150 mg + Nivolumab	Part B: AUC0-4H of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 1	6842.88 h*ng/mL	Standard Deviation 3251.994
Part A - Debio 1143 150 mg + Nivolumab	Part B: AUC0-4H of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 22	7167.67 h*ng/mL	Standard Deviation 4161.553
Part A - Debio 1143 150 mg + Nivolumab	Part B: AUC0-4H of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 3 Day 1	5674.83 h*ng/mL	Standard Deviation 757.917
Part A - Debio 1143 150 mg + Nivolumab	Part B: AUC0-4H of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 1	2737.56 h*ng/mL	Standard Deviation 1280.628
Part A - Debio 1143 150 mg + Nivolumab	Part B: AUC0-4H of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 22	5938.44 h*ng/mL	Standard Deviation 2187.477
Part A - Debio 1143 150 mg + Nivolumab	Part B: AUC0-4H of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 3 Day 1	3409.44 h*ng/mL	Standard Deviation 2059.973
Part A - Debio 1143 200 mg + Nivolumab	Part B: AUC0-4H of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 3 Day 1	1587.21 h*ng/mL	Standard Deviation 1838.618
Part A - Debio 1143 200 mg + Nivolumab	Part B: AUC0-4H of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 1	3440.08 h*ng/mL	Standard Deviation 2274.864
Part A - Debio 1143 200 mg + Nivolumab	Part B: AUC0-4H of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 1	5552.70 h*ng/mL	Standard Deviation 4559.658
Part A - Debio 1143 200 mg + Nivolumab	Part B: AUC0-4H of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 3 Day 1	3248.39 h*ng/mL	Standard Deviation 3165.907
Part A - Debio 1143 200 mg + Nivolumab	Part B: AUC0-4H of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 22	5668.59 h*ng/mL	Standard Deviation 3536.016
Part A - Debio 1143 200 mg + Nivolumab	Part B: AUC0-4H of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 22	10100.42 h*ng/mL	Standard Deviation 3889.091
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Part B: AUC0-4H of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 22	3218.09 h*ng/mL	Standard Deviation 1137.952
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Part B: AUC0-4H of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 3 Day 1	2117.23 h*ng/mL	Standard Deviation 970.849
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Part B: AUC0-4H of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 1	2255.49 h*ng/mL	Standard Deviation 1153.863
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Part B: AUC0-4H of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 3 Day 1	2381.90 h*ng/mL	Standard Deviation 2767.733
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Part B: AUC0-4H of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 22	5404.44 h*ng/mL	Standard Deviation 4032.522
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Part B: AUC0-4H of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 1	5149.10 h*ng/mL	Standard Deviation 1922.588
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Part B: AUC0-4H of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 22	7085.47 h*ng/mL	Standard Deviation 5196.199
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Part B: AUC0-4H of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 3 Day 1	2128.83 h*ng/mL	Standard Deviation 1581.498
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Part B: AUC0-4H of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 22	6801.02 h*ng/mL	Standard Deviation 1841.871
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Part B: AUC0-4H of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 1	3140.29 h*ng/mL	Standard Deviation 1139.965
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Part B: AUC0-4H of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 1	7619.75 h*ng/mL	Standard Deviation 3287.399
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Part B: AUC0-4H of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 3 Day 1	5920.77 h*ng/mL	Standard Deviation 2206.953

Secondary

Part B: Cmax of Debio 1143 and Debio 1143-MET1

Time frame: Cycle 1: predose, 1.5, 4 hours post-dose on Days 1 and 22; Cycle 3: predose, 1.5, 4 hours post-dose on Day 1 (each cycle = 28 days)

Arm	Measure	Group	Value (MEAN)	Dispersion
Part A - Debio 1143 150 mg + Nivolumab	Part B: Cmax of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 1	2839.5 ng/mL	Standard Deviation 1293.43
Part A - Debio 1143 150 mg + Nivolumab	Part B: Cmax of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 22	2786.3 ng/mL	Standard Deviation 1591.66
Part A - Debio 1143 150 mg + Nivolumab	Part B: Cmax of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 3 Day 1	2183.3 ng/mL	Standard Deviation 496.42
Part A - Debio 1143 150 mg + Nivolumab	Part B: Cmax of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 1	1077.38 ng/mL	Standard Deviation 473.925
Part A - Debio 1143 150 mg + Nivolumab	Part B: Cmax of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 22	1888.50 ng/mL	Standard Deviation 668.598
Part A - Debio 1143 150 mg + Nivolumab	Part B: Cmax of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 3 Day 1	808.67 ng/mL	Standard Deviation 748.505
Part A - Debio 1143 200 mg + Nivolumab	Part B: Cmax of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 3 Day 1	738.00 ng/mL	Standard Deviation 724.077
Part A - Debio 1143 200 mg + Nivolumab	Part B: Cmax of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 1	1070.71 ng/mL	Standard Deviation 808.979
Part A - Debio 1143 200 mg + Nivolumab	Part B: Cmax of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 1	2266.1 ng/mL	Standard Deviation 1830.74
Part A - Debio 1143 200 mg + Nivolumab	Part B: Cmax of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 3 Day 1	1726.0 ng/mL	Standard Deviation 1094.6
Part A - Debio 1143 200 mg + Nivolumab	Part B: Cmax of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 22	2065.8 ng/mL	Standard Deviation 1205.31
Part A - Debio 1143 200 mg + Nivolumab	Part B: Cmax of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 22	2886.67 ng/mL	Standard Deviation 915.394
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Part B: Cmax of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 22	1327.0 ng/mL	Standard Deviation 416.3
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Part B: Cmax of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 3 Day 1	975.3 ng/mL	Standard Deviation 179.7
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Part B: Cmax of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 1	1190.00 ng/mL	Standard Deviation 439.686
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Part B: Cmax of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 3 Day 1	965.33 ng/mL	Standard Deviation 982.152
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Part B: Cmax of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 22	1782.80 ng/mL	Standard Deviation 1074.434
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Part B: Cmax of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 1	2331.3 ng/mL	Standard Deviation 823.28
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Part B: Cmax of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 22	2289.10 ng/mL	Standard Deviation 1414.128
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Part B: Cmax of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 3 Day 1	891.29 ng/mL	Standard Deviation 488.887
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Part B: Cmax of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 22	2891.0 ng/mL	Standard Deviation 860.28
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Part B: Cmax of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 1	1320.00 ng/mL	Standard Deviation 483.919
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Part B: Cmax of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 1	2850.0 ng/mL	Standard Deviation 1413.87
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Part B: Cmax of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 3 Day 1	2271.4 ng/mL	Standard Deviation 954.8

Secondary

Part B: Serum Trough Concentration of Nivolumab

Time frame: Cycle 1: predose, 1.5 hours post-dose on Day 15; Cycle 3: predose, 1.5 hours post-dose on Days 1 and Day 15; Cycle 6: predose on Day 1 (each cycle = 28 days)

Arm	Measure	Group	Value (MEAN)	Dispersion
Part A - Debio 1143 150 mg + Nivolumab	Part B: Serum Trough Concentration of Nivolumab	Cycle 1 Day 15	21312.5 ng/mL	Standard Deviation 2942.51
Part A - Debio 1143 150 mg + Nivolumab	Part B: Serum Trough Concentration of Nivolumab	Cycle 3 Day 1	34100.0 ng/mL	—
Part A - Debio 1143 200 mg + Nivolumab	Part B: Serum Trough Concentration of Nivolumab	Cycle 6 Day 1	40400.0 ng/mL	—
Part A - Debio 1143 200 mg + Nivolumab	Part B: Serum Trough Concentration of Nivolumab	Cycle 1 Day 15	25414.3 ng/mL	Standard Deviation 8766.68
Part A - Debio 1143 200 mg + Nivolumab	Part B: Serum Trough Concentration of Nivolumab	Cycle 3 Day 1	40600.0 ng/mL	—
Part A - Debio 1143 200 mg + Nivolumab	Part B: Serum Trough Concentration of Nivolumab	Cycle 3 Day 15	45400.0 ng/mL	—
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Part B: Serum Trough Concentration of Nivolumab	Cycle 1 Day 15	33725.0 ng/mL	Standard Deviation 17751.28
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Part B: Serum Trough Concentration of Nivolumab	Cycle 3 Day 1	43866.7 ng/mL	Standard Deviation 11670.08
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Part B: Serum Trough Concentration of Nivolumab	Cycle 1 Day 15	22332.0 ng/mL	Standard Deviation 8864.61
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Part B: Serum Trough Concentration of Nivolumab	Cycle 3 Day 15	58400.0 ng/mL	Standard Deviation 10492.22

Secondary

Part B: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1

Time frame: Cycle 1: predose on Days 8 and 22; Cycle 3: predose on Day 1 (each cycle = 28 days)

Arm	Measure	Group	Value (MEAN)	Dispersion
Part A - Debio 1143 150 mg + Nivolumab	Part B: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 22	658.50 ng/mL	Standard Deviation 557.846
Part A - Debio 1143 150 mg + Nivolumab	Part B: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 3 Day 1	2.84 ng/mL	Standard Deviation 0.255
Part A - Debio 1143 150 mg + Nivolumab	Part B: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 8	198.05 ng/mL	Standard Deviation 143.494
Part A - Debio 1143 150 mg + Nivolumab	Part B: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 3 Day 1	3.24 ng/mL	Standard Deviation 0.721
Part A - Debio 1143 150 mg + Nivolumab	Part B: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET: Cycle 1 Day 8	693.33 ng/mL	Standard Deviation 983.009
Part A - Debio 1143 150 mg + Nivolumab	Part B: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 22	150.29 ng/mL	Standard Deviation 80.118
Part A - Debio 1143 200 mg + Nivolumab	Part B: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET: Cycle 1 Day 8	1917.89 ng/mL	Standard Deviation 1826.669
Part A - Debio 1143 200 mg + Nivolumab	Part B: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 3 Day 1	11.08 ng/mL	Standard Deviation 12.056
Part A - Debio 1143 200 mg + Nivolumab	Part B: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 8	167.20 ng/mL	Standard Deviation 112.649
Part A - Debio 1143 200 mg + Nivolumab	Part B: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 22	221.60 ng/mL	Standard Deviation 140.039
Part A - Debio 1143 200 mg + Nivolumab	Part B: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 22	2103.33 ng/mL	Standard Deviation 1410.308
Part A - Debio 1143 200 mg + Nivolumab	Part B: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 3 Day 1	14.35 ng/mL	Standard Deviation 11.809
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Part B: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 8	192.86 ng/mL	Standard Deviation 130.457
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Part B: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET: Cycle 1 Day 8	1005.20 ng/mL	Standard Deviation 1150.843
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Part B: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 22	830.20 ng/mL	Standard Deviation 827.444
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Part B: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 3 Day 1	3.50 ng/mL	Standard Deviation 0.318
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Part B: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 22	130.92 ng/mL	Standard Deviation 50.555
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Part B: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 3 Day 1	10.30 ng/mL	Standard Deviation 3.751
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Part B: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 8	143.39 ng/mL	Standard Deviation 44.663
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Part B: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 1 Day 22	146.39 ng/mL	Standard Deviation 50.852
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Part B: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143: Cycle 3 Day 1	4.94 ng/mL	Standard Deviation 2.137
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Part B: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET: Cycle 1 Day 8	1118.40 ng/mL	Standard Deviation 710.33
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Part B: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1	Debio 1143-MET1: Cycle 1 Day 22	1113.04 ng/mL	Standard Deviation 811.962

Secondary

Parts A and B: Change From Baseline in Weight

Time frame: From Baseline up to end of treatment (up to approximately 1.53 years in Part A and up to 1 year in Part B)

Population: Safety analysis set included all participants who were enrolled and received at least one dose of any study drug. Overall number of participants analyzed indicates the number of participants with data available for analysis.

Arm	Measure	Value (MEAN)	Dispersion
Part A - Debio 1143 150 mg + Nivolumab	Parts A and B: Change From Baseline in Weight	-5.57 kilograms (kg)	Standard Deviation 5.705
Part A - Debio 1143 200 mg + Nivolumab	Parts A and B: Change From Baseline in Weight	-10.00 kilograms (kg)	Standard Deviation 9.416
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Change From Baseline in Weight	-4.33 kilograms (kg)	Standard Deviation 3.888
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Change From Baseline in Weight	-4.00 kilograms (kg)	Standard Deviation 6.557
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Change From Baseline in Weight	-0.80 kilograms (kg)	Standard Deviation 5.415
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Change From Baseline in Weight	-1.11 kilograms (kg)	Standard Deviation 1.68

Secondary

Parts A and B: Disease Control Rate (DCR)

DCR was calculated as the percentage of participants with disease control. Disease control was derived as any CR, PR, or stable disease reported during the study. CR is defined by the disappearance of all target lesions and reduction of any pathological lymph nodes in short axis to \<10 mm. PR is defined by at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameter.

Time frame: From the start of study treatment until disease progression/recurrence was documented, a new systemic anti-cancer therapy was started or analysis cut-off, whichever occurred first (up to approximately 2.08 years in Part A and 2.05 years in Part B)

Population: Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.

Arm	Measure	Value (NUMBER)
Part A - Debio 1143 150 mg + Nivolumab	Parts A and B: Disease Control Rate (DCR)	66.7 percentage of participants
Part A - Debio 1143 200 mg + Nivolumab	Parts A and B: Disease Control Rate (DCR)	50.0 percentage of participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Disease Control Rate (DCR)	25.0 percentage of participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Disease Control Rate (DCR)	75.0 percentage of participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Disease Control Rate (DCR)	37.5 percentage of participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Disease Control Rate (DCR)	45.5 percentage of participants

Secondary

Parts A and B: Median Duration of Response (DOR)

DOR is defined as the time, in months, between date of the initial response (PR or CR) or date of first reduction of 50% in carbohydrate antigen 125 (CA-125), and date of the first documented disease progression or death due to any cause, whichever occurs first. CR is defined by the disappearance of all target lesions and reduction of any pathological lymph nodes in short axis to \<10 mm. PR is defined by at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameter. Data is reported as Kaplan-Meier product-limit estimates.

Arm	Measure	Value (MEDIAN)
Part A - Debio 1143 200 mg + Nivolumab	Parts A and B: Median Duration of Response (DOR)	NA months
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Median Duration of Response (DOR)	NA months

Secondary

Parts A and B: Number of Participants With Change From Baseline in Temperature Reported as TEAEs

Change from baseline in temperature reported as TEAEs included pyrexia. A TEAE is any new, related or non-related, undesirable medical occurrence or change of an existing condition in a participant that occurs during the treatment-emergent period, starting or worsening on or after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy - 1 day, whichever occurs first.

Time frame: From Baseline up to end of treatment (up to approximately 1.53 years in Part A and up to 1 year in Part B)

Population: Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Part A - Debio 1143 150 mg + Nivolumab	Parts A and B: Number of Participants With Change From Baseline in Temperature Reported as TEAEs	0 Participants
Part A - Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Change From Baseline in Temperature Reported as TEAEs	2 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Change From Baseline in Temperature Reported as TEAEs	1 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Change From Baseline in Temperature Reported as TEAEs	1 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Change From Baseline in Temperature Reported as TEAEs	0 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Change From Baseline in Temperature Reported as TEAEs	3 Participants

Secondary

Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings

ECG parameters comprised of PR Interval \[millisecond (msec)\], QRS Interval (msec), QT Interval (msec), QTcB Interval (msec), QTcF Interval (msec), heart rate (HR) (bpm), RR interval (msec), derived HR (msec), calculated as 60000/RR interval \[for data checking only: should be within 5% of HR\]. Marked abnormal criteria for ECG parameters included absolute values QRS interval: \< 50 msec, \> 110 msec; absolute values for QT interval, QTcB interval: \>450 msec, \> 480 msec, \> 500 msec, QTcF: \> 480 msec, \> 500 msec; change from baseline values for QTcB interval, and QTcF: \>30 msec increase from baseline, \>60 msec increase from baseline. Data for highest on-treatment change from baseline as per the markedly abnormal criteria for ECG parameters are reported. On-treatment is the period of time between the first and last administration of any study drug. Participants with at least one markedly abnormal change from baseline value in the above categories are reported.

Time frame: From Baseline up to end of treatment (up to approximately 1.53 years in Part A and up to 1 year in Part B)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Part A - Debio 1143 150 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QRS duration: >110 msec	0 Participants
Part A - Debio 1143 150 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QT Interval: >450 msec	0 Participants
Part A - Debio 1143 150 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QT Interval: >480 msec	0 Participants
Part A - Debio 1143 150 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcB Interval: >450 msec	2 Participants
Part A - Debio 1143 150 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcB Interval: >480 msec	0 Participants
Part A - Debio 1143 150 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcB Interval: >500 msec	0 Participants
Part A - Debio 1143 150 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcB Interval: >30 msec increase from baseline	0 Participants
Part A - Debio 1143 150 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcB Interval: >60 msec increase from baseline	0 Participants
Part A - Debio 1143 150 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcB Interval: >30 msec or >60 msec increase from baseline	0 Participants
Part A - Debio 1143 150 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcF Interval: >480 msec	0 Participants
Part A - Debio 1143 150 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcF Interval: >500 msec	0 Participants
Part A - Debio 1143 150 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcF Interval: >30 msec increase from baseline	0 Participants
Part A - Debio 1143 150 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcF Interval: >60 msec increase from baseline	0 Participants
Part A - Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QT Interval: >480 msec	1 Participants
Part A - Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcF Interval: >60 msec increase from baseline	0 Participants
Part A - Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QRS duration: >110 msec	3 Participants
Part A - Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcB Interval: >60 msec increase from baseline	0 Participants
Part A - Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcF Interval: >500 msec	0 Participants
Part A - Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcB Interval: >500 msec	1 Participants
Part A - Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QT Interval: >450 msec	1 Participants
Part A - Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcB Interval: >30 msec or >60 msec increase from baseline	4 Participants
Part A - Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcF Interval: >30 msec increase from baseline	1 Participants
Part A - Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcF Interval: >480 msec	1 Participants
Part A - Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcB Interval: >480 msec	0 Participants
Part A - Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcB Interval: >30 msec increase from baseline	4 Participants
Part A - Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcB Interval: >450 msec	2 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcB Interval: >30 msec increase from baseline	3 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcB Interval: >30 msec or >60 msec increase from baseline	3 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcB Interval: >60 msec increase from baseline	0 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcB Interval: >450 msec	3 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QT Interval: >480 msec	0 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QRS duration: >110 msec	1 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcB Interval: >480 msec	0 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QT Interval: >450 msec	2 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcF Interval: >500 msec	0 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcB Interval: >500 msec	0 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcF Interval: >30 msec increase from baseline	2 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcF Interval: >480 msec	0 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcF Interval: >60 msec increase from baseline	0 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcB Interval: >60 msec increase from baseline	1 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QT Interval: >480 msec	0 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcB Interval: >450 msec	5 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcF Interval: >30 msec increase from baseline	3 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcB Interval: >480 msec	0 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcB Interval: >500 msec	1 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcB Interval: >30 msec increase from baseline	5 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcB Interval: >30 msec or >60 msec increase from baseline	6 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcF Interval: >480 msec	0 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcF Interval: >60 msec increase from baseline	1 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcF Interval: >500 msec	1 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QRS duration: >110 msec	1 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QT Interval: >450 msec	1 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcB Interval: >30 msec or >60 msec increase from baseline	3 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcB Interval: >500 msec	0 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcF Interval: >480 msec	0 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QT Interval: >480 msec	0 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcF Interval: >30 msec increase from baseline	1 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QT Interval: >450 msec	3 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcF Interval: >500 msec	0 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcB Interval: >480 msec	1 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QRS duration: >110 msec	2 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcF Interval: >60 msec increase from baseline	0 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcB Interval: >60 msec increase from baseline	0 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcB Interval: >30 msec increase from baseline	3 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcB Interval: >450 msec	1 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcF Interval: >500 msec	0 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcB Interval: >30 msec or >60 msec increase from baseline	6 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcF Interval: >30 msec increase from baseline	4 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcB Interval: >500 msec	0 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcB Interval: >30 msec increase from baseline	6 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QT Interval: >480 msec	0 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcB Interval: >450 msec	5 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcF Interval: >480 msec	0 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QT Interval: >450 msec	0 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcB Interval: >60 msec increase from baseline	0 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcB Interval: >480 msec	1 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QRS duration: >110 msec	0 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings	QTcF Interval: >60 msec increase from baseline	0 Participants

Secondary

Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Vital Signs

Vital sign parameters assessed comprise of systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate. Markedly abnormal criteria for vital signs include SBP \[millimeters of mercury (mmHg)\]: ≤ 90 mmHg OR change from baseline ≤ -20 mmHg, ≥ 140 mmHg OR change from baseline ≥ 20 mmHg; DBP (mmHg): ≤ 60 mmHg OR change from baseline ≤ -20 mmHg, ≥ 90 mmHg OR change from baseline ≥ 20 mmHg; Heart rate \[beats per minute (bpm)\]: ≤ 50 bpm OR change from baseline ≤ -20 bpm, ≥ 100 bpm OR change from baseline ≥ 20 bpm.

Time frame: From Baseline up to end of treatment (up to approximately 1.53 years in Part A and up to 1 year in Part B)

Population: Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Part A - Debio 1143 150 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Vital Signs	0 Participants
Part A - Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Vital Signs	0 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Vital Signs	0 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Vital Signs	0 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Vital Signs	0 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Vital Signs	0 Participants

Secondary

Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)

The ECOG-PS was used to assess the effect of disease progression on participants' daily activities. ECOG-PS is graded as follows: Grade 0 - fully active, able to carry on all pre-disease performance without restriction; Grade 1 - restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; Grade 2 - ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50% of waking hours; Grade 3 - capable of only limited self-care, confined to bed or chair for more than 50% of waking hours; Grade 4 - completely disabled, cannot carry on any self-care, totally confined to bed or chair; Grade 5 - dead. Shift values from baseline grade to worst on-treatment grade and missing values were reported.

Time frame: From Baseline up to end of treatment (up to approximately 1.53 years in Part A and up to 1 year in Part B)

Population: Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Part A - Debio 1143 150 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Shift From Grade 0 to Grade 2	0 Participants
Part A - Debio 1143 150 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Shift From Grade 0 to Grade 1	0 Participants
Part A - Debio 1143 150 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Shift From Grade 0 to Grade 0	1 Participants
Part A - Debio 1143 150 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Shift From Grade 0 to Grade 3	0 Participants
Part A - Debio 1143 150 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Shift From Grade 1 to Grade 1	2 Participants
Part A - Debio 1143 150 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Shift From Grade 1 to Grade 2	0 Participants
Part A - Debio 1143 150 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Shift From Grade 1 to Grade 3	0 Participants
Part A - Debio 1143 150 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Missing	0 Participants
Part A - Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Shift From Grade 0 to Grade 3	0 Participants
Part A - Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Missing	0 Participants
Part A - Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Shift From Grade 0 to Grade 0	3 Participants
Part A - Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Shift From Grade 1 to Grade 3	0 Participants
Part A - Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Shift From Grade 1 to Grade 2	1 Participants
Part A - Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Shift From Grade 0 to Grade 2	1 Participants
Part A - Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Shift From Grade 0 to Grade 1	2 Participants
Part A - Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Shift From Grade 1 to Grade 1	1 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Shift From Grade 0 to Grade 1	3 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Shift From Grade 0 to Grade 2	2 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Shift From Grade 0 to Grade 3	0 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Missing	0 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Shift From Grade 1 to Grade 1	2 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Shift From Grade 1 to Grade 2	1 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Shift From Grade 1 to Grade 3	0 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Shift From Grade 0 to Grade 0	0 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Shift From Grade 1 to Grade 3	2 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Shift From Grade 1 to Grade 2	1 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Shift From Grade 1 to Grade 1	3 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Shift From Grade 0 to Grade 0	2 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Shift From Grade 0 to Grade 2	0 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Shift From Grade 0 to Grade 3	0 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Missing	0 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Shift From Grade 0 to Grade 1	0 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Missing	0 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Shift From Grade 0 to Grade 0	1 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Shift From Grade 1 to Grade 1	2 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Shift From Grade 1 to Grade 2	1 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Shift From Grade 1 to Grade 3	0 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Shift From Grade 0 to Grade 1	2 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Shift From Grade 0 to Grade 2	1 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Shift From Grade 0 to Grade 3	1 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Missing	1 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Shift From Grade 1 to Grade 1	5 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Shift From Grade 0 to Grade 2	0 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Shift From Grade 0 to Grade 3	0 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Shift From Grade 1 to Grade 2	0 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Shift From Grade 0 to Grade 1	4 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Shift From Grade 1 to Grade 3	0 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	Shift From Grade 0 to Grade 0	1 Participants

Secondary

Parts A and B: Number of Participants With TEAEs Including Laboratory Abnormalities Leading to Treatment Discontinuations and Dose Modifications

Time frame: From the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B)

Population: Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Part A - Debio 1143 150 mg + Nivolumab	Parts A and B: Number of Participants With TEAEs Including Laboratory Abnormalities Leading to Treatment Discontinuations and Dose Modifications	TEAEs Leading to Discontinuation of Nivolumab	1 Participants
Part A - Debio 1143 150 mg + Nivolumab	Parts A and B: Number of Participants With TEAEs Including Laboratory Abnormalities Leading to Treatment Discontinuations and Dose Modifications	TEAEs Leading to Discontinuation of Debio 1143	1 Participants
Part A - Debio 1143 150 mg + Nivolumab	Parts A and B: Number of Participants With TEAEs Including Laboratory Abnormalities Leading to Treatment Discontinuations and Dose Modifications	TEAEs Leading to Dose Modification of Nivolumab	2 Participants
Part A - Debio 1143 150 mg + Nivolumab	Parts A and B: Number of Participants With TEAEs Including Laboratory Abnormalities Leading to Treatment Discontinuations and Dose Modifications	TEAEs Leading to Dose Modification of Debio 1143	2 Participants
Part A - Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With TEAEs Including Laboratory Abnormalities Leading to Treatment Discontinuations and Dose Modifications	TEAEs Leading to Discontinuation of Debio 1143	1 Participants
Part A - Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With TEAEs Including Laboratory Abnormalities Leading to Treatment Discontinuations and Dose Modifications	TEAEs Leading to Discontinuation of Nivolumab	1 Participants
Part A - Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With TEAEs Including Laboratory Abnormalities Leading to Treatment Discontinuations and Dose Modifications	TEAEs Leading to Dose Modification of Debio 1143	5 Participants
Part A - Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With TEAEs Including Laboratory Abnormalities Leading to Treatment Discontinuations and Dose Modifications	TEAEs Leading to Dose Modification of Nivolumab	6 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With TEAEs Including Laboratory Abnormalities Leading to Treatment Discontinuations and Dose Modifications	TEAEs Leading to Discontinuation of Nivolumab	0 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With TEAEs Including Laboratory Abnormalities Leading to Treatment Discontinuations and Dose Modifications	TEAEs Leading to Discontinuation of Debio 1143	0 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With TEAEs Including Laboratory Abnormalities Leading to Treatment Discontinuations and Dose Modifications	TEAEs Leading to Dose Modification of Debio 1143	5 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With TEAEs Including Laboratory Abnormalities Leading to Treatment Discontinuations and Dose Modifications	TEAEs Leading to Dose Modification of Nivolumab	4 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With TEAEs Including Laboratory Abnormalities Leading to Treatment Discontinuations and Dose Modifications	TEAEs Leading to Dose Modification of Nivolumab	5 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With TEAEs Including Laboratory Abnormalities Leading to Treatment Discontinuations and Dose Modifications	TEAEs Leading to Discontinuation of Nivolumab	3 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With TEAEs Including Laboratory Abnormalities Leading to Treatment Discontinuations and Dose Modifications	TEAEs Leading to Discontinuation of Debio 1143	3 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With TEAEs Including Laboratory Abnormalities Leading to Treatment Discontinuations and Dose Modifications	TEAEs Leading to Dose Modification of Debio 1143	5 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With TEAEs Including Laboratory Abnormalities Leading to Treatment Discontinuations and Dose Modifications	TEAEs Leading to Dose Modification of Debio 1143	3 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With TEAEs Including Laboratory Abnormalities Leading to Treatment Discontinuations and Dose Modifications	TEAEs Leading to Dose Modification of Nivolumab	1 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With TEAEs Including Laboratory Abnormalities Leading to Treatment Discontinuations and Dose Modifications	TEAEs Leading to Discontinuation of Debio 1143	1 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With TEAEs Including Laboratory Abnormalities Leading to Treatment Discontinuations and Dose Modifications	TEAEs Leading to Discontinuation of Nivolumab	1 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With TEAEs Including Laboratory Abnormalities Leading to Treatment Discontinuations and Dose Modifications	TEAEs Leading to Discontinuation of Nivolumab	2 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With TEAEs Including Laboratory Abnormalities Leading to Treatment Discontinuations and Dose Modifications	TEAEs Leading to Dose Modification of Debio 1143	4 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With TEAEs Including Laboratory Abnormalities Leading to Treatment Discontinuations and Dose Modifications	TEAEs Leading to Discontinuation of Debio 1143	2 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With TEAEs Including Laboratory Abnormalities Leading to Treatment Discontinuations and Dose Modifications	TEAEs Leading to Dose Modification of Nivolumab	4 Participants

Secondary

Parts A and B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Including Laboratory Abnormalities Reported as TEAEs, and Serious Adverse Events (SAEs)

An adverse event (AE) is any untoward medical occurrence in a clinical trial participant administered a medicinal product that does not necessarily have a causal relationship with this treatment. A TEAE is any new, related or non-related, undesirable medical occurrence or change of an existing condition in a participant that occurs during the treatment-emergent period, starting or worsening on or after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy - 1 day, whichever occurs first. An SAE is defined as any untoward medical occurrence that at any dose results in death; is life-threatening (i.e., puts the participant at immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect, or is otherwise medically significant.

Population: Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Part A - Debio 1143 150 mg + Nivolumab	Parts A and B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Including Laboratory Abnormalities Reported as TEAEs, and Serious Adverse Events (SAEs)	TEAEs	3 Participants
Part A - Debio 1143 150 mg + Nivolumab	Parts A and B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Including Laboratory Abnormalities Reported as TEAEs, and Serious Adverse Events (SAEs)	SAEs	0 Participants
Part A - Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Including Laboratory Abnormalities Reported as TEAEs, and Serious Adverse Events (SAEs)	TEAEs	8 Participants
Part A - Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Including Laboratory Abnormalities Reported as TEAEs, and Serious Adverse Events (SAEs)	SAEs	8 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Including Laboratory Abnormalities Reported as TEAEs, and Serious Adverse Events (SAEs)	TEAEs	8 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Including Laboratory Abnormalities Reported as TEAEs, and Serious Adverse Events (SAEs)	SAEs	0 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Including Laboratory Abnormalities Reported as TEAEs, and Serious Adverse Events (SAEs)	TEAEs	8 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Including Laboratory Abnormalities Reported as TEAEs, and Serious Adverse Events (SAEs)	SAEs	6 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Including Laboratory Abnormalities Reported as TEAEs, and Serious Adverse Events (SAEs)	TEAEs	8 Participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Including Laboratory Abnormalities Reported as TEAEs, and Serious Adverse Events (SAEs)	SAEs	5 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Including Laboratory Abnormalities Reported as TEAEs, and Serious Adverse Events (SAEs)	TEAEs	11 Participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Including Laboratory Abnormalities Reported as TEAEs, and Serious Adverse Events (SAEs)	SAEs	5 Participants

Secondary

Parts A and B: OS Rate at Months 12 and 18

OS is defined as the time elapsed, in months, between treatment initiation and death from any cause. Data for OS rate is reported as Kaplan-Meier product-limit estimates and includes Brookmeyer-Crowley confidence intervals.

Time frame: Months 12 and 18

Arm	Measure	Group	Value (NUMBER)
Part A - Debio 1143 150 mg + Nivolumab	Parts A and B: OS Rate at Months 12 and 18	Month 12	1.0 proportion of participants
Part A - Debio 1143 150 mg + Nivolumab	Parts A and B: OS Rate at Months 12 and 18	Month 18	NA proportion of participants
Part A - Debio 1143 200 mg + Nivolumab	Parts A and B: OS Rate at Months 12 and 18	Month 12	0.5 proportion of participants
Part A - Debio 1143 200 mg + Nivolumab	Parts A and B: OS Rate at Months 12 and 18	Month 18	NA proportion of participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: OS Rate at Months 12 and 18	Month 12	0.9 proportion of participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: OS Rate at Months 12 and 18	Month 18	0.5 proportion of participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: OS Rate at Months 12 and 18	Month 12	0.3 proportion of participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: OS Rate at Months 12 and 18	Month 18	0.1 proportion of participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: OS Rate at Months 12 and 18	Month 12	0.4 proportion of participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: OS Rate at Months 12 and 18	Month 18	0.4 proportion of participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: OS Rate at Months 12 and 18	Month 12	0.4 proportion of participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: OS Rate at Months 12 and 18	Month 18	0.3 proportion of participants

Secondary

Parts A and B: Overall Survival (OS)

OS is defined as the time elapsed, in months, between treatment initiation and death from any cause.

Time frame: From the start of study treatment until death from any cause, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B)

Population: Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.

Arm	Measure	Value (MEDIAN)
Part A - Debio 1143 150 mg + Nivolumab	Parts A and B: Overall Survival (OS)	13.8 months
Part A - Debio 1143 200 mg + Nivolumab	Parts A and B: Overall Survival (OS)	NA months
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Overall Survival (OS)	17.5 months
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Overall Survival (OS)	4.7 months
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Overall Survival (OS)	5.2 months
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Overall Survival (OS)	11.7 months

Secondary

Parts A and B: PFS Rate at Months 6 and 12

PFS is defined as duration elapsed between treatment initiation and tumor progression or death from any cause, whichever occurs first. Data for PFS rate is reported as Kaplan-Meier product-limit estimates and includes Brookmeyer-Crowley confidence intervals.

Time frame: Months 6 and 12

Population: Safety analysis set included all participants who were enrolled and received at least one dose of any study drug. Number analyzed indicates the number of participants analyzed at the given time points. No participants were analyzed at Month 12 in Part B.

Arm	Measure	Group	Value (NUMBER)
Part A - Debio 1143 150 mg + Nivolumab	Parts A and B: PFS Rate at Months 6 and 12	Month 12	0.0 proportion of participants
Part A - Debio 1143 150 mg + Nivolumab	Parts A and B: PFS Rate at Months 6 and 12	Month 6	0.0 proportion of participants
Part A - Debio 1143 200 mg + Nivolumab	Parts A and B: PFS Rate at Months 6 and 12	Month 6	0.2 proportion of participants
Part A - Debio 1143 200 mg + Nivolumab	Parts A and B: PFS Rate at Months 6 and 12	Month 12	0.2 proportion of participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: PFS Rate at Months 6 and 12	Month 6	0.1 proportion of participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: PFS Rate at Months 6 and 12	Month 6	0.0 proportion of participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: PFS Rate at Months 6 and 12	Month 6	0.1 proportion of participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: PFS Rate at Months 6 and 12	Month 6	0.2 proportion of participants

Secondary

Parts A and B: Progression Free Survival (PFS)

PFS duration is defined as the time, in months, elapsed between treatment initiation and tumor progression or death from any cause, whichever occurs first.

Time frame: From the start of study treatment until disease progression/recurrence or death from any cause, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B)

Population: Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.

Arm	Measure	Value (MEDIAN)
Part A - Debio 1143 150 mg + Nivolumab	Parts A and B: Progression Free Survival (PFS)	2.3 months
Part A - Debio 1143 200 mg + Nivolumab	Parts A and B: Progression Free Survival (PFS)	2.3 months
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Progression Free Survival (PFS)	1.8 months
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Progression Free Survival (PFS)	1.9 months
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Progression Free Survival (PFS)	1.2 months
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Progression Free Survival (PFS)	1.8 months

Secondary

Parts A and B: Time to Response (TTR)

The average of the time taken in days for PR is reported. PR is defined by at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameter.

Arm	Measure	Value (MEAN)
Part A - Debio 1143 200 mg + Nivolumab	Parts A and B: Time to Response (TTR)	82 days
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Time to Response (TTR)	52 days

Secondary

Parts A and B: Unconfirmed Objective Response Rate (uORR)

uORR was calculated as the percentage of participants with unconfirmed objective response per RECIST v1.1. Unconfirmed objective response is an unconfirmed best overall response of PR or CR. Objective response was derived as any PR or CR recorded after the start of study treatment until disease progression/recurrence was documented, a new systemic anti-cancer therapy was started or analysis cut-off, whichever occurred first. CR is defined by the disappearance of all target lesions and reduction of any pathological lymph nodes in short axis to \<10 mm. PR is defined by at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameter.

Population: Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.

Arm	Measure	Value (NUMBER)
Part A - Debio 1143 150 mg + Nivolumab	Parts A and B: Unconfirmed Objective Response Rate (uORR)	0.0 percentage of participants
Part A - Debio 1143 200 mg + Nivolumab	Parts A and B: Unconfirmed Objective Response Rate (uORR)	25.0 percentage of participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Unconfirmed Objective Response Rate (uORR)	0.0 percentage of participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Unconfirmed Objective Response Rate (uORR)	0.0 percentage of participants
Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Unconfirmed Objective Response Rate (uORR)	0.0 percentage of participants
Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab	Parts A and B: Unconfirmed Objective Response Rate (uORR)	9.1 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026

Study to Assess Safety and Efficacy of the Second Mitochondrial-derived Activator of Caspases (SMAC) Mimetic Debio 1143

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Part A: Number of Participants With Dose-limiting Toxicities (DLTs)

Part B: Confirmed Objective Response Rate (ORR)

Part A: Area Under the Curve From Time 0 to 4 Hours (AUC0-4H) of Debio 1143 and Debio 1143-MET1

Part A: Area Under the Curve From Time 0 to 8 Hours (AUC0-8H) of Debio 1143 and Debio 1143-MET1

Part A: Confirmed Objective Response Rate (ORR)

Part A: Maximum Observed Concentration (Cmax) of Debio 1143 and Debio 1143-MET1

Part A: Serum Trough Concentration of Nivolumab

Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1

Part B: AUC0-4H of Debio 1143 and Debio 1143-MET1

Part B: Cmax of Debio 1143 and Debio 1143-MET1

Part B: Serum Trough Concentration of Nivolumab

Part B: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1

Parts A and B: Change From Baseline in Weight

Parts A and B: Disease Control Rate (DCR)

Parts A and B: Median Duration of Response (DOR)

Parts A and B: Number of Participants With Change From Baseline in Temperature Reported as TEAEs

Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings

Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Vital Signs

Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)

Parts A and B: Number of Participants With TEAEs Including Laboratory Abnormalities Leading to Treatment Discontinuations and Dose Modifications

Parts A and B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Including Laboratory Abnormalities Reported as TEAEs, and Serious Adverse Events (SAEs)

Parts A and B: OS Rate at Months 12 and 18

Parts A and B: Overall Survival (OS)

Parts A and B: PFS Rate at Months 6 and 12

Parts A and B: Progression Free Survival (PFS)

Parts A and B: Time to Response (TTR)

Parts A and B: Unconfirmed Objective Response Rate (uORR)