Advanced CancerPhase 1/2NCT02658890

An Investigational Immuno-therapy Study of BMS-986205 Given in Combination With Nivolumab and in Combination With Both Nivolumab and Ipilimumab in Cancers That Are Advanced or Have Spread

A Phase 1/2 study testing BMS-986205, Nivolumab and Ipilimumab in people with Advanced Cancer and Melanoma, run by Bristol-Myers Squibb at 47 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Advanced Cancer, Melanoma, Non-Small Cell Lung Cancer
What is being tested?: BMS-986205, Nivolumab and Ipilimumab
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 627 participants
Where: 47 sitesin 11 countries
Study dates: 14 Apr 2016to 26 Oct 2021
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

During dose escalation, subjects with advanced solid tumors that have progressed following at least one standard regimen
During cohort expansion, subjects with advanced cancer that either have received at least one prior therapy or are treatment naive, depending on the specified tumor type
Subjects must have measurable disease
Subject must consent to provide previously collected tumor tissue and a tumor biopsy during screening.
At least 4 weeks since any previous treatment for cancer
Must be able to swallow pills or capsules
Eastern Cooperative Oncology Group(ECOG) Performance Status 0-1

Who cannot join

Active or chronic autoimmune diseases
Uncontrolled or significant cardiovascular disease
History of any chronic Hepatitis, active Hepatitis B or C, human immunodeficiency virus (HIV), or acquired immune deficiency syndrome (AIDS)
Chronic hepatitis: Positive test for Hepatitis B virus surface antigen or Hepatitis C antibody (except for subjects with hepatocellular carcinoma)
Active central nervous system (CNS) metastases and CNS metastases as the only sites of disease
Active infection
Other protocol defined inclusion/exclusion criteria could apply

Trial locations and contacts

47 sites in 11 countries.

Country

City, postcode or hospital

47 sites in 11 countries

United States15 sites

Local Institution - 0005
Atlanta, Georgia, 30322
Local Institution - 0048
Atlanta, Georgia, 30342
Local Institution - 0027
Chicago, Illinois, 60637
Local Institution - 0030
Cleveland, Ohio, 44195
Local Institution - 0049
Detroit, Michigan, 48201
Local Institution - 0033
Hackensack, New Jersey, 07601
Local Institution - 0026
La Jolla, California, 92093-0698
Local Institution - 0051
Lutherville, Maryland, 21093
Local Institution - 0043
Nashville, Tennessee, 37232
Local Institution - 0041
New York, New York, 10016
Local Institution - 0034
Philadelphia, Pennsylvania, 19111-2412
Local Institution - 0057
Pittsburgh, Pennsylvania, 15232
Local Institution - 0006
St Louis, Missouri, 63110
Local Institution - 0035
Tampa, Florida, 33612-9497
Local Institution - 0028
Tucson, Arizona, 85724-5024

Other trials in United States

Australia7 sites

Local Institution - 0044
Brisbane, Queensland, 4102
Local Institution - 0008
Clayton, Victoria, 3168
Local Institution - 0004
Melbourne, Victoria, 3000
Local Institution - 0047
Nedlands, Western Australia, 6009
Local Institution - 0045
North Sydney, New South Wales, 2146
Local Institution - 0029
Sydney, New South Wales, 2010
Local Institution - 0046
Westmead, New South Wales, 2145

Other trials in Australia

France7 sites

Local Institution - 0040
Lille, 59037
Local Institution - 0024
Lyon, 69373
Local Institution - 0053
Marseille, 13385
Local Institution - 0052
Nantes, 44093
Local Institution - 0025
Paris, 75005
Local Institution - 0023
Toulouse, 31100
Local Institution - 0022
Villejuif, 94800

Other trials in France

Canada5 sites

Local Institution - 0003
Edmonton, Alberta, T6G 1Z2
Local Institution
Greenfield Park, Quebec, J4V 2H1
Local Institution - 0036
Montreal, Quebec, H3T 1E2
Local Institution - 0001
Toronto, Ontario, M5G 1Z5
Local Institution - 0002
Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Italy4 sites

Local Institution - 0010
Milan, 20132
Local Institution - 0011
Milan, 20133
Local Institution - 0012
Milan, 20141
Local Institution - 0009
Rozzano MI, 20089

Other trials in Italy

Spain3 sites

Local Institution - 0017
Barcelona, 08035
Local Institution - 0016
Madrid, 28040
Local Institution - 0018
Madrid, 28050

Other trials in Spain

Germany2 sites

Local Institution - 0019
Essen, 45147
Local Institution - 0013
Heilbronn, 74078

Other trials in Germany

Finland1 site

Local Institution - 0059
Helsinki, 00180

Other trials in Finland

Norway1 site

Local Institution - 0054
Oslo, 0424

Other trials in Norway

Poland1 site

Local Institution - 0042
Warsaw, Masovian Voivodeship, 02-781

Other trials in Poland

Sweden1 site

Local Institution - 0055
Solna, 171 64

Other trials in Sweden

About this study

Official title: A Phase 1/2a Study of BMS-986205 Administered in Combination With Nivolumab (Anti-PD-1 Monoclonal Antibody) and in Combination With Both Nivolumab and Ipilimumab (Anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors

The purpose of the study is to determine safety and effectiveness of experimental medication BMS-986205 when combined with Nivolumab and in combination with both Nivolumab and Ipilimumab in patients with cancers that are advanced or have spread. Pharmacokinetics and pharmacodynamics of BMS-986205 when combined with Nivolumab and in combination with Nivolumab and Ipilimumab in this patient population will also be assessed.

Conditions: Advanced Cancer, Melanoma, Non-Small Cell Lung Cancer
Being tested: BMS-986205, Nivolumab, Ipilimumab
Medical subject headings: Melanoma, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BMS-986205Drug
NivolumabDrug
Also called BMS-936558, ANTI-PD1
IpilimumabDrug
Also called BMS-734016, ANTI-CTLA-4

Study groups in NCT02658890
Study group	Role	What they receive
Combination Therapy (Dose Escalation)	Experimental	BMS 986205 + Nivolumab specified dose at specified intervals. Receives: Drug: BMS-986205; Drug: Nivolumab
Combination Therapy (Dose Expansion)	Experimental	BMS 986205 + Nivolumab specified dose at specified intervals. Receives: Drug: BMS-986205; Drug: Nivolumab
Combination Therapy 2 (Dose Expansion)	Experimental	BMS 986205 + both Nivolumab and ipilimumab specified dose at specified intervals Receives: Drug: BMS-986205; Drug: Nivolumab; Drug: Ipilimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths
Number of participants with adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation and deaths.
Measured: From first dose to 100 days after last dose (up to 15 months)
Number of Treated Participant With Laboratory Abnormalities - Thyroid
The number of treated participants who experienced a laboratory abnormality of the thyroid during the course of the study.
Free T3 (FT3) Free T4 (FT4) Thyroid stimulating hormone (TSH) Lower Limit of Normal (LLN) Upper limit of normal (ULN) Results reported in International System of Units (SI)
Measured: From first dose to 100 days after last dose (up to 15 months)
Number of Treated Participant With Laboratory Abnormalities - Liver
The number of treated participants who experienced a laboratory abnormality of the liver during the course of the study.
Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) Upper Limit of Normal (ULN) Results reported in International System of Units (SI)
Measured: From first dose to 100 days after last dose (up to 15 months)
Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3
Best overall response (BOR) is defined as the best response designation over the study as a whole. Complete response (CR) or partial response (PR) determinations included in the BOR assessment must be confirmed by a second scan performed no less than 4 weeks after the criteria for response are first met. For those participants who have surgical resection, only pre-surgical tumor assessments will be considered in the determination of BOR. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions. Progressive Disease. (PD): At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. Appearance of 1 or more new lesions is also considered progression. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Measured: From first dose to the last tumor assessment prior to subsequent therapy (up to a maximum of 185 weeks)
Percentage of Participants With an Objective Response Rate (ORR)- Parts 2 and 3
Objective response rate (ORR) is defined as the percentage of all treated participants whose BOR is either a complete response (CR) or partial response (PR). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions.
Measured: From first dose to the last tumor assessment prior to subsequent therapy (up to a maximum of 185 weeks)
Median Duration of Response (DoR) - Parts 2 and 3
Duration of response (DoR) was computed for all treated subjects with a best overall response (BOR) of complete response (CR) or partial response (PR) and is defined as the time between the date of first response and the date of disease progression or death, whichever occurs first. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions.
Measured: From first dose to the date of disease progression, death, or until participants withdraw from the study, whichever occurs first (up to a maximum of 185 weeks)
Progression Free Survival Rate (PFSR) at 24 Weeks - Parts 2 and 3
Progression free survival rate (PFSR) is defined as the percentage of participants who remain progression free and surviving at 24 weeks. Reported values are estimates derived from Kaplan-Meier analyses.
Measured: At 24 weeks after first dose
Progression Free Survival Rate (PFSR) at 1 Year - Parts 2 and 3
Progression free survival rate (PFSR) is defined as the percentage of participants who remain progression free and surviving at 1 year. Reported values are estimates derived from Kaplan-Meier analyses.
Measured: At 1 year
Progression Free Survival Rate (PFSR) at 2 Years - Parts 2 and 3
Progression free survival rate (PFSR) is defined as the percentage of participants who remain progression free and surviving at 2 years. Reported values are estimates derived from Kaplan-Meier analyses.
Measured: At 2 years

Secondary outcomes (16)

Cmax
Cmax is defined as the maximum observed plasma concentration. Pharmacokinetic parameters measured here are for BMS-986205.
Measured: At cycle 0 day 1 and day 14 [cycle 0= up to 2 weeks]
Tmax
Tmax is defined as the time of maximum observed plasma concentration. Pharmacokinetic parameters measured here are for BMS-986205.
Measured: At cycle 0 day 1 and day 14 [cycle 0= up to 2 weeks]
AUC(TAU)
AUC(TAU) is defined as the area under the concentration-time curve in 1 dosing interval. Pharmacokinetic parameters measured here are for BMS-986205.
Measured: Cycle 0 Day 1 (0, 1, 2, 3, 4, 6, 8, 24 hours post-dose), Cycle 0 Day 14 (0, 1, 2, 3, 4, 6, 8, 24 hours post-dose)
Ctrough
Ctrough is defined as the trough observed plasma concentration at the end of the dosing interval.
Measured: At cycles 0 [up to 2 weeks] and at cycles 3, 5, 7, 10, 11, 13, 15 [each cycle is up to 4 weeks]
CLT/F
CLT/F is defined as the apparent total body clearance. Pharmacokinetic parameters measured here are for BMS-986205.
Measured: At Cycle 0 Day 14 [cycle 0 = up to 2 weeks]
Accumulation Index (AI) - AUC(TAU)
Accumulation index (AI) of AUC(TAU) is calculated based on the ratio of AUC(TAU) at steady state to after the first dose. Pharmacokinetic parameters measured here are for BMS-986205.
Measured: Cycle 0 Day 1 (0, 1, 2, 3, 4, 6, 8, 24 hours post-dose), Cycle 0 Day 14 (0, 1, 2, 3, 4, 6, 8, 24 hours post-dose)
Accumulation Index (AI) - Cmax
Accumulation index (AI) of Cmax is calculated based on the ratio of Cmax at steady state to after the first dose. Pharmacokinetic parameters measured here are for BMS-986205.
Measured: At Cycle 0 Day 14 [cycle 0 = up to 2 weeks]
Change From Baseline in Serum Kynurenine
Pharmacodynamics assessed by change from baseline in serum kynurenine. Changes in kynurenine expression were evaluated in serum samples from participants treated using liquid chromatography with tandem mass spectrometry (LC-MS/MS). Kynurenine is an important metabolite of the IDO-1 Enzyme. Change in Kynurenine levels from baseline is an important indicator of BMS-986205 (IDO1 inhibitor) pharmacodynamic activity.
Measured: At baseline (cycle 1, day 1) and at cycle 1, day 15 [cycle 1 = up to 4 weeks]
Percent Change From Baseline in Serum Kynurenine
Pharmacodynamics assessed by change from baseline in serum kynurenine. Changes in kynurenine expression were evaluated in serum samples from participants treated using liquid chromatography with tandem mass spectrometry (LC-MS/MS). Kynurenine is an important metabolite of the IDO-1 Enzyme. Change in Kynurenine levels from baseline is an important indicator of BMS-986205 (IDO1 inhibitor) pharmacodynamic activity.
Measured: At baseline (cycle 1, day 1) and at cycle 1, day 15 [cycle 1 = up to 4 weeks]
Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies
Best overall response (BOR) is defined as the best response designation over the study as a whole. Complete response (CR) or partial response (PR) determinations included in the BOR assessment must be confirmed by a second scan performed no less than 4 weeks after the criteria for response are first met. For those participants who have surgical resection, only pre-surgical tumor assessments will be considered in the determination of BOR. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions. Progressive Disease. (PD): At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. Appearance of 1 or more new lesions is also considered progression. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Measured: From first dose to the last tumor assessment prior to subsequent therapy (up to a maximum of 185 weeks)
Percentage of Participants With an Objective Response Rate (ORR) - Part 1 and Clinical Pharmacology Substudies
Objective response rate (ORR) is defined as the percentage of all treated participants whose BOR is either a complete response (CR) or partial response (PR). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions. CR+PR confidence interval based on the Clopper and Pearson method.
Measured: From first dose to the last tumor assessment prior to subsequent therapy (up to a maximum of 185 weeks)
Median Duration of Response (DoR) - Part 1 and Clinical Pharmacology Substudies
Duration of response (DoR) was computed for all treated subjects with a best overall response (BOR) of complete response (CR) or partial response (PR) and is defined as the time between the date of first response and the date of disease progression or death, whichever occurs first. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions.
Measured: From first dose to the last tumor assessment prior to subsequent therapy (up to a maximum of 185 weeks)
Progression Free Survival Rate (PFSR) at 24 Weeks - Part 1 and Clinical Pharmacology Substudies
Progression free survival rate (PFSR) is defined as the percentage of participants who remain progression free and surviving at 24 weeks. Reported values are estimates derived from Kaplan-Meier analyses.
Measured: At 24 weeks after first dose
Progression Free Survival Rate (PFSR) at 1 Year - Part 1 and Clinical Pharmacology Substudies
Progression free survival rate (PFSR) is defined as the percentage of participants who remain progression free and surviving at 1 year. Reported values are estimates derived from Kaplan-Meier analyses.
Measured: At 1 year
Progression Free Survival Rate (PFSR) at 2 Years - Part 1 and Clinical Pharmacology Substudies
Progression free survival rate (PFSR) is defined as the percentage of participants who remain progression free and surviving at 2 years. Reported values are estimates derived from Kaplan-Meier analyses.
Measured: At 2 years
Number of Participants With a Positive Anti-Drug Antibody (ADA) Test
A participant with at least one ADA-positive sample relative to baseline after initiation of treatment with nivolumab or ipilimumab. ADA-Positive after initiation of treatment was defined as (1) an ADA detected (positive seroconversion) sample in a subject for whom ADA is not detected at baseline, or (2) an ADA detected sample with ADA titer to be at least 4-fold or greater (≥) than baseline positive titer.
Measured: From first dose to last dose (up to approximately 48 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Apr 201626 Oct 2021

First posted20 Jan 2016 (estimated)
Study start14 Apr 2016
Primary completion26 Oct 2021
Study completion26 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Advanced CancerStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 627 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02658890
Sponsor's protocol ID: CA017-003
Other IDs: 2015-004914-79, 2015
Status last verified: Aug 2023
First submitted: 14 Jan 2016
Last updated: 28 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms

All Advanced Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/2a Study of BMS-986205 Administered in Combination With Nivolumab (Anti-PD-1 Monoclonal Antibody) and in Combination With Both Nivolumab and Ipilimumab (Anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors
ClinicalTrials.gov ID: NCT02658890
Acronym / sponsor ID: CA017-003
Conditions: Advanced Cancer, Melanoma, Non-Small Cell Lung Cancer
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 627 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: 14 Apr 2016 (actual)
Primary completion: 26 Oct 2021 (actual)
Study completion: 26 Oct 2021 (actual)
First posted: 20 Jan 2016 (estimated)
Results: Posted 28 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Combination Therapy (Dose Escalation)	Experimental	Drug: BMS-986205, Drug: NivolumabBMS 986205 + Nivolumab specified dose at specified intervals.
Combination Therapy (Dose Expansion)	Experimental	Drug: BMS-986205, Drug: NivolumabBMS 986205 + Nivolumab specified dose at specified intervals.
Combination Therapy 2 (Dose Expansion)	Experimental	Drug: BMS-986205, Drug: Nivolumab, Drug: IpilimumabBMS 986205 + both Nivolumab and ipilimumab specified dose at specified intervals

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

During dose escalation, subjects with advanced solid tumors that have progressed following at least one standard regimen
During cohort expansion, subjects with advanced cancer that either have received at least one prior therapy or are treatment naive, depending on the specified tumor type
Subjects must have measurable disease
Subject must consent to provide previously collected tumor tissue and a tumor biopsy during screening.
At least 4 weeks since any previous treatment for cancer

Key exclusion criteria (7 listed)

Active or chronic autoimmune diseases
Uncontrolled or significant cardiovascular disease
History of any chronic Hepatitis, active Hepatitis B or C, human immunodeficiency virus (HIV), or acquired immune deficiency syndrome (AIDS)
Chronic hepatitis: Positive test for Hepatitis B virus surface antigen or Hepatitis C antibody (except for subjects with hepatocellular carcinoma)
Active central nervous system (CNS) metastases and CNS metastases as the only sites of disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BMS-986205	Drug	Combination Therapy (Dose Escalation), Combination Therapy (Dose Expansion), Combination Therapy 2 (Dose Expansion)
NivolumabAlso: BMS-936558, ANTI-PD1	Drug	Combination Therapy (Dose Escalation), Combination Therapy (Dose Expansion), Combination Therapy 2 (Dose Expansion)
IpilimumabAlso: BMS-734016, ANTI-CTLA-4	Drug	Combination Therapy 2 (Dose Expansion)

Primary outcome

Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths
Time frame: From first dose to 100 days after last dose (up to 15 months)
Number of participants with adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation and deaths.
Number of Treated Participant With Laboratory Abnormalities - Thyroid
Time frame: From first dose to 100 days after last dose (up to 15 months)
The number of treated participants who experienced a laboratory abnormality of the thyroid during the course of the study. Free T3 (FT3) Free T4 (FT4) Thyroid stimulating hormone (TSH) Lower Limit of Normal (LLN) Upper limit of normal (ULN) Results reported in International System of Units (SI)
Number of Treated Participant With Laboratory Abnormalities - Liver
Time frame: From first dose to 100 days after last dose (up to 15 months)
The number of treated participants who experienced a laboratory abnormality of the liver during the course of the study. Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) Upper Limit of Normal (ULN) Results reported in International System of Units (SI)
Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3
Time frame: From first dose to the last tumor assessment prior to subsequent therapy (up to a maximum of 185 weeks)
Best overall response (BOR) is defined as the best response designation over the study as a whole. Complete response (CR) or partial response (PR) determinations included in the BOR assessment must be confirmed by a second scan performed no less than 4 weeks after the criteria for response are first met. For those participants who have surgical resection, only pre-surgical tumor assessments will be considered in the determination of BOR. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions. Progressive Disease. (PD): At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. Appearance of 1 or more new lesions is also considered progression. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Percentage of Participants With an Objective Response Rate (ORR)- Parts 2 and 3
Time frame: From first dose to the last tumor assessment prior to subsequent therapy (up to a maximum of 185 weeks)
Objective response rate (ORR) is defined as the percentage of all treated participants whose BOR is either a complete response (CR) or partial response (PR). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions.
Median Duration of Response (DoR) - Parts 2 and 3
Time frame: From first dose to the date of disease progression, death, or until participants withdraw from the study, whichever occurs first (up to a maximum of 185 weeks)
Duration of response (DoR) was computed for all treated subjects with a best overall response (BOR) of complete response (CR) or partial response (PR) and is defined as the time between the date of first response and the date of disease progression or death, whichever occurs first. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions.
Progression Free Survival Rate (PFSR) at 24 Weeks - Parts 2 and 3
Time frame: At 24 weeks after first dose
Progression free survival rate (PFSR) is defined as the percentage of participants who remain progression free and surviving at 24 weeks. Reported values are estimates derived from Kaplan-Meier analyses.
Progression Free Survival Rate (PFSR) at 1 Year - Parts 2 and 3
Time frame: At 1 year
Progression free survival rate (PFSR) is defined as the percentage of participants who remain progression free and surviving at 1 year. Reported values are estimates derived from Kaplan-Meier analyses.
Progression Free Survival Rate (PFSR) at 2 Years - Parts 2 and 3
Time frame: At 2 years
Progression free survival rate (PFSR) is defined as the percentage of participants who remain progression free and surviving at 2 years. Reported values are estimates derived from Kaplan-Meier analyses.

16 secondary outcomes

Cmax
Time frame: At cycle 0 day 1 and day 14 [cycle 0= up to 2 weeks]
Tmax
Time frame: At cycle 0 day 1 and day 14 [cycle 0= up to 2 weeks]
AUC(TAU)
Time frame: Cycle 0 Day 1 (0, 1, 2, 3, 4, 6, 8, 24 hours post-dose), Cycle 0 Day 14 (0, 1, 2, 3, 4, 6, 8, 24 hours post-dose)
Ctrough
Time frame: At cycles 0 [up to 2 weeks] and at cycles 3, 5, 7, 10, 11, 13, 15 [each cycle is up to 4 weeks]
CLT/F
Time frame: At Cycle 0 Day 14 [cycle 0 = up to 2 weeks]
Accumulation Index (AI) - AUC(TAU)
Time frame: Cycle 0 Day 1 (0, 1, 2, 3, 4, 6, 8, 24 hours post-dose), Cycle 0 Day 14 (0, 1, 2, 3, 4, 6, 8, 24 hours post-dose)
Accumulation Index (AI) - Cmax
Time frame: At Cycle 0 Day 14 [cycle 0 = up to 2 weeks]
Change From Baseline in Serum Kynurenine
Time frame: At baseline (cycle 1, day 1) and at cycle 1, day 15 [cycle 1 = up to 4 weeks]
Percent Change From Baseline in Serum Kynurenine
Time frame: At baseline (cycle 1, day 1) and at cycle 1, day 15 [cycle 1 = up to 4 weeks]
Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies
Time frame: From first dose to the last tumor assessment prior to subsequent therapy (up to a maximum of 185 weeks)
Percentage of Participants With an Objective Response Rate (ORR) - Part 1 and Clinical Pharmacology Substudies
Time frame: From first dose to the last tumor assessment prior to subsequent therapy (up to a maximum of 185 weeks)
Median Duration of Response (DoR) - Part 1 and Clinical Pharmacology Substudies
Time frame: From first dose to the last tumor assessment prior to subsequent therapy (up to a maximum of 185 weeks)
Progression Free Survival Rate (PFSR) at 24 Weeks - Part 1 and Clinical Pharmacology Substudies
Time frame: At 24 weeks after first dose
Progression Free Survival Rate (PFSR) at 1 Year - Part 1 and Clinical Pharmacology Substudies
Time frame: At 1 year
Progression Free Survival Rate (PFSR) at 2 Years - Part 1 and Clinical Pharmacology Substudies
Time frame: At 2 years
Number of Participants With a Positive Anti-Drug Antibody (ADA) Test
Time frame: From first dose to last dose (up to approximately 48 weeks)

Results and safety

Results posted to the registry on 28 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part 1: BMS25+NIV240(ESC)	7	7
Part 1: BMS50+NIV240(ESC)	11	11
Part 1: BMS100+NIV240(ESC)	12	12
Part 1: BMS200+NIV240(ESC)	18	18
Part 1: BMS400+NIV240(ESC)	7	7
Part 2: Exp Cervical + (IDO 100)	18	18
Part 2: Exp Cervical + (IDO 200)	17	17
Part 2: Exp Pancreatic	22	22
Part 2: Exp DLBCL	36	35
Part 2: Exp SCCHN + (IDO 100)	15	15
Part 2: Exp SCCHN + (IDO 200)	14	14
Part 2: Exp Bladder + (IDO 100)	14	14
Part 2: Exp Bladder + (IDO 200)	16	16
Part 2: Exp ML I-O Naive	79	79
Part 2: Exp ML BRAF-MT	9	9
Part 2: Exp ML BRAF-MT- NIVO	6	6
Part 2: Exp ML Anti-PDL1	37	37
Part 2: Exp ML Anti-PDL1+CTLA4	17	17
Part 2: Exp NSCLC I-O Naive	80	80
Part 2: Exp NSCLC Anti-PDL1	41	41
Part 2: Exp ASST	32	32
Part 2: Exp Renal	42	42
Part 3: Melanoma and NSCLC	41	41
Unplanned - BMS50	1	1
Unplanned	1	1
QTc Substudy	20	20
Food Effect/ Relative BA (FE BA) Substudy	14	14

Primary outcome: Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths

Time frame: From first dose to 100 days after last dose (up to 15 months). Count of participants. Unit: Participants

Measure	Part 1: BMS50 (ESC) n = 1	Part 1: BMS400 (ESC) n = 1	Unplanned - BMS50 n = 1	Part 1: BMS25+NIV240(ESC) n = 7	Part 1: BMS50+NIV240(ESC) n = 10	Part 1: BMS100+NIV240(ESC) n = 12	Part 1: BMS200+NIV240(ESC) n = 18	Part 1: BMS400+NIV240(ESC) n = 6	Part 2: Exp Cervical + (IDO 100) n = 18	Part 2: Exp Cervical + (IDO 200) n = 17	Part 2: Exp Pancreatic n = 22	Part 2: Exp DLBCL n = 35	Part 2: Exp SCCHN + (IDO 100) n = 15	Part 2: Exp SCCHN + (IDO 200) n = 14	Part 2: Exp Bladder + (IDO 100) n = 14	Part 2: Exp Bladder + (IDO 200) n = 16	Part 2: Exp ML I-O Naive n = 79	Part 2: Exp ML BRAF-MT n = 9	Part 2: Exp ML BRAF-MT- NIVO n = 6	Part 2: Exp ML Anti-PDL1 n = 37	Part 2: Exp ML Anti-PDL1+CTLA4 n = 17	Part 2: Exp NSCLC I-O Naive n = 80	Part 2: Exp NSCLC Anti-PDL1 n = 41	Part 2: Exp ASST n = 32	Part 2: Exp Renal n = 42	Part 3: Melanoma and NSCLC n = 41	Unplanned n = 1
Adverse Events	1	1	0	7

Primary outcome: Number of Treated Participant With Laboratory Abnormalities - Thyroid

Time frame: From first dose to 100 days after last dose (up to 15 months). Count of participants. Unit: Participants

Measure	Part 1: BMS50 (ESC) n = 0	Part 1: BMS400 (ESC) n = 0	Unplanned - BMS50 n = 0	Part 1: BMS25+NIV240(ESC) n = 6	Part 1: BMS50+NIV240(ESC) n = 8	Part 1: BMS100+NIV240(ESC) n = 9	Part 1: BMS200+NIV240(ESC) n = 12	Part 1: BMS400+NIV240(ESC) n = 4	Part 2: Exp Cervical + (IDO 100) n = 13	Part 2: Exp Cervical + (IDO 200) n = 14	Part 2: Exp Pancreatic n = 13	Part 2: Exp DLBCL n = 23	Part 2: Exp SCCHN + (IDO 100) n = 11	Part 2: Exp SCCHN + (IDO 200) n = 10	Part 2: Exp Bladder + (IDO 100) n = 14	Part 2: Exp Bladder + (IDO 200) n = 14	Part 2: Exp ML I-O Naive n = 77	Part 2: Exp ML BRAF-MT n = 8	Part 2: Exp ML BRAF-MT- NIVO n = 6	Part 2: Exp ML Anti-PDL1 n = 32	Part 2: Exp ML Anti-PDL1+CTLA4 n = 14	Part 2: Exp NSCLC I-O Naive n = 67	Part 2: Exp NSCLC Anti-PDL1 n = 34	Part 2: Exp ASST n = 27	Part 2: Exp Renal n = 38	Part 3: Melanoma and NSCLC n = 38	Unplanned n = 1
TSH > ULN	0	0	0	1	1

Primary outcome: Number of Treated Participant With Laboratory Abnormalities - Liver

Time frame: From first dose to 100 days after last dose (up to 15 months). Count of participants. Unit: Participants

Measure	Part 1: BMS50 (ESC) n = 1	Part 1: BMS400 (ESC) n = 1	Unplanned - BMS50 n = 0	Part 1: BMS25+NIV240(ESC) n = 7	Part 1: BMS50+NIV240(ESC) n = 10	Part 1: BMS100+NIV240(ESC) n = 12	Part 1: BMS200+NIV240(ESC) n = 18	Part 1: BMS400+NIV240(ESC) n = 6	Part 2: Exp Cervical + (IDO 100) n = 18	Part 2: Exp Cervical + (IDO 200) n = 17	Part 2: Exp Pancreatic n = 22	Part 2: Exp DLBCL n = 34	Part 2: Exp SCCHN + (IDO 100) n = 14	Part 2: Exp SCCHN + (IDO 200) n = 14	Part 2: Exp Bladder + (IDO 100) n = 14	Part 2: Exp Bladder + (IDO 200) n = 16	Part 2: Exp ML I-O Naive n = 79	Part 2: Exp ML BRAF-MT n = 9	Part 2: Exp ML BRAF-MT- NIVO n = 6	Part 2: Exp ML Anti-PDL1 n = 37	Part 2: Exp ML Anti-PDL1+CTLA4 n = 17	Part 2: Exp NSCLC I-O Naive n = 80	Part 2: Exp NSCLC Anti-PDL1 n = 40	Part 2: Exp ASST n = 32	Part 2: Exp Renal n = 41	Part 3: Melanoma and NSCLC n = 41	Unplanned n = 1
ALT or AST > 3X ULN	0	1	0	2

Primary outcome: Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3

Time frame: From first dose to the last tumor assessment prior to subsequent therapy (up to a maximum of 185 weeks). Count of participants. Unit: Participants

Measure	Part 2: Exp Cervical + (IDO 100) n = 18	Part 2: Exp Cervical + (IDO 200) n = 17	Part 2: Exp Pancreatic n = 22	Part 2: Exp DLBCL n = 35	Part 2: Exp SCCHN + (IDO 100) n = 15	Part 2: Exp SCCHN + (IDO 200) n = 14	Part 2: Exp Bladder + (IDO 100) n = 14	Part 2: Exp Bladder + (IDO 200) n = 16	Part 2: Exp ML I-O Naive n = 79	Part 2: Exp ML BRAF-MT n = 9	Part 2: Exp ML BRAF-MT- NIVO n = 6	Part 2: Exp ML Anti-PDL1 n = 37	Part 2: Exp ML Anti-PDL1+CTLA4 n = 17	Part 2: Exp NSCLC I-O Naive n = 80	Part 2: Exp NSCLC Anti-PDL1 n = 41	Part 2: Exp ASST n = 32	Part 2: Exp Renal n = 42	Part 3: Melanoma and NSCLC n = 41
Complete response (CR)	0	0	0	0	0	1	1	2	15	3	2	0	0	2	0	0	0	5
Partial response (PR)	0	4	1	5	2	3	5	3	17	1	1	1	2	12	4	3	8	12
Stable disease (SD)	6	8	1	5	6	4

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 5 years and 8 months). SAEs and other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1: BMS50 (ESC)	1 of 1 (100%)	1 of 1 (100%)	1 of 1
Part 1: BMS400 (ESC)	1 of 1 (100%)	0 of 1 (0%)	1 of 1
Unplanned - BMS50	0 of 1 (0%)	0 of 1 (0%)	0 of 1
Part 1: BMS25+NIV240(ESC)	5 of 7 (71.4%)	7 of 7 (100%)	6 of 7
Part 1: BMS50+NIV240(ESC)	6 of 10 (60%)	10 of 10 (100%)	8 of 10
Part 1: BMS100+NIV240(ESC)	8 of 12 (66.7%)	12 of 12 (100%)	9 of 12
Part 1: BMS200+NIV240(ESC)	12 of 18 (66.7%)	18 of 18 (100%)	15 of 18
Part 1: BMS400+NIV240(ESC	5 of 6 (83.3%)	6 of 6 (100%)	4 of 6
Part 2: Exp Cervical + (IDO 100)	15 of 18 (83.3%)	18 of 18 (100%)	16 of 18
Part 2: Exp Cervical + (IDO 200)	14 of 17 (82.4%)	17 of 17 (100%)	12 of 17
Part 2: Exp Pancreatic	18 of 22 (81.8%)	20 of 22 (90.9%)	21 of 22
Part 2: Exp DLBCL	27 of 35 (77.1%)	29 of 35 (82.9%)	21 of 35
Part 2: Exp SCCHN + (IDO 100)	12 of 15 (80%)	13 of 15 (86.7%)	12 of 15
Part 2: Exp SCCHN + (IDO 200)	9 of 14 (64.3%)	14 of 14 (100%)	12 of 14
Part 2: Exp Bladder + (IDO 100)	12 of 14 (85.7%)	14 of 14 (100%)	9 of 14
Part 2: Exp Bladder + (IDO 200)	11 of 16 (68.8%)	15 of 16 (93.8%)	12 of 16
Part 2: Exp ML I-O Naive	42 of 79 (53.2%)	78 of 79 (98.7%)	34 of 79

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BMS Clinical Trial InformationLink provided by the sponsor.
BMS Clinical Trial Patient RecruitingLink provided by the sponsor.

Related trials for Advanced Cancer

Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

47 sites in 11 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BMS-986205, Nivolumab and Ipilimumab in people with Advanced Cancer and Melanoma, run by Bristol-Myers Squibb at 47 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in United States, Australia, France, Canada, Italy and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths (time frame: From first dose to 100 days after last dose (up to 15 months)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02658890.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2023.