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

NCT02658890 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: CA017-0032015-004914-79
• Study Type: interventional
• Target: 627
• Locations: 11 countries
• Sites: 47

Brief Summary

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

Outcome Measures

Primary Outcomes (9)

• 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.

  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)

  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)

  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.

  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.

  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.

  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.

  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.

  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.

  At 2 years

Secondary Outcomes (16)

• Cmax

  At cycle 0 day 1 and day 14 [cycle 0= up to 2 weeks]

• Tmax

  At cycle 0 day 1 and day 14 [cycle 0= up to 2 weeks]

• AUC(TAU)

  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

  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

  At Cycle 0 Day 14 [cycle 0 = up to 2 weeks]

Study Arms (3)

Combination Therapy (Dose Escalation)

EXPERIMENTAL

BMS 986205 + Nivolumab specified dose at specified intervals.

Drug: BMS-986205; Drug: Nivolumab

Combination Therapy (Dose Expansion)

EXPERIMENTAL

BMS 986205 + Nivolumab specified dose at specified intervals.

Drug: BMS-986205; Drug: Nivolumab

Combination Therapy 2 (Dose Expansion)

EXPERIMENTAL

BMS 986205 + both Nivolumab and ipilimumab specified dose at specified intervals

Drug: BMS-986205; Drug: Nivolumab; Drug: Ipilimumab

Interventions

BMS-986205 DRUG

Combination Therapy (Dose Escalation); Combination Therapy (Dose Expansion); Combination Therapy 2 (Dose Expansion)

Nivolumab DRUG

Also known as: BMS-936558, ANTI-PD1

Combination Therapy (Dose Escalation); Combination Therapy (Dose Expansion); Combination Therapy 2 (Dose Expansion)

Ipilimumab DRUG

Also known as: BMS-734016, ANTI-CTLA-4

Combination Therapy 2 (Dose Expansion)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (47)

Local Institution - 0028

Tucson, Arizona, 85724-5024, United States

Location

Local Institution - 0026

La Jolla, California, 92093-0698, United States

Location

Local Institution - 0035

Tampa, Florida, 33612-9497, United States

Location

Local Institution - 0005

Atlanta, Georgia, 30322, United States

Location

Local Institution - 0048

Atlanta, Georgia, 30342, United States

Location

Local Institution - 0027

Chicago, Illinois, 60637, United States

Location

Local Institution - 0051

Lutherville, Maryland, 21093, United States

Location

Local Institution - 0049

Detroit, Michigan, 48201, United States

Location

Local Institution - 0006

St Louis, Missouri, 63110, United States

Location

Local Institution - 0033

Hackensack, New Jersey, 07601, United States

Location

Local Institution - 0041

New York, New York, 10016, United States

Location

Local Institution - 0030

Cleveland, Ohio, 44195, United States

Location

Local Institution - 0034

Philadelphia, Pennsylvania, 19111-2412, United States

Location

Local Institution - 0057

Pittsburgh, Pennsylvania, 15232, United States

Location

Local Institution - 0043

Nashville, Tennessee, 37232, United States

Location

Local Institution - 0045

North Sydney, New South Wales, 2146, Australia

Location

Local Institution - 0029

Sydney, New South Wales, 2010, Australia

Location

Local Institution - 0046

Westmead, New South Wales, 2145, Australia

Location

Local Institution - 0044

Brisbane, Queensland, 4102, Australia

Location

Local Institution - 0008

Clayton, Victoria, 3168, Australia

Location

Local Institution - 0004

Melbourne, Victoria, 3000, Australia

Location

Local Institution - 0047

Nedlands, Western Australia, 6009, Australia

Location

Local Institution - 0003

Edmonton, Alberta, T6G 1Z2, Canada

Location

Local Institution - 0002

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Local Institution - 0001

Toronto, Ontario, M5G 1Z5, Canada

Location

Local Institution

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Local Institution - 0036

Montreal, Quebec, H3T 1E2, Canada

Location

Local Institution - 0059

Helsinki, 00180, Finland

Location

Local Institution - 0040

Lille, 59037, France

Location

Local Institution - 0024

Lyon, 69373, France

Location

Local Institution - 0053

Marseille, 13385, France

Location

Local Institution - 0052

Nantes, 44093, France

Location

Local Institution - 0025

Paris, 75005, France

Location

Local Institution - 0023

Toulouse, 31100, France

Location

Local Institution - 0022

Villejuif, 94800, France

Location

Local Institution - 0019

Essen, 45147, Germany

Location

Local Institution - 0013

Heilbronn, 74078, Germany

Location

Local Institution - 0010

Milan, 20132, Italy

Location

Local Institution - 0011

Milan, 20133, Italy

Location

Local Institution - 0012

Milan, 20141, Italy

Location

Local Institution - 0009

Rozzano MI, 20089, Italy

Location

Local Institution - 0054

Oslo, 0424, Norway

Location

Local Institution - 0042

Warsaw, Masovian Voivodeship, 02-781, Poland

Location

Local Institution - 0017

Barcelona, 08035, Spain

Location

Local Institution - 0016

Madrid, 28040, Spain

Location

Local Institution - 0018

Madrid, 28050, Spain

Location

Local Institution - 0055

Solna, 171 64, Sweden

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Melanoma; Carcinoma, Non-Small-Cell Lung

Interventions

linrodostat; Nivolumab; spartalizumab; Ipilimumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email:

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2016
• First Posted: January 20, 2016
• Study Start: April 14, 2016
• Primary Completion: October 26, 2021
• Study Completion: October 26, 2021
• Last Updated: August 28, 2023
• Results First Posted: August 28, 2023

Record last verified: 2023-08

Locations

NO (1); PL (1); US (15); FI (1); FR (7); ES (3); AU (7); CA (5); SE (1); DE (2); IT (4)