This website is for US healthcare professionals

close-icon

Log In to Bolder Science

or

Don't have an account? Sign Up

close-icon

Please enter your email address.

You will receive a link to create a new password via email.

Log In

close-icon

Create an Account

or
  • 8 characters minimum
  • First character may not be a number
  • Last character may not be a number
close-icon

Welcome and thank you for creating an account!

At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

Condition Categories

Condition categories are pulled directly from ClinicalTrials.gov. Choose 1 or more condition categories that you are interested in:

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

Set a default location

An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers

  • Clinicaltrials.gov identifier

    NCT03994601

  • Recruitment Status

    Recruiting

  • First Posted

    June 21, 2019

  • Last update posted

    February 17, 2020

Study Description

Brief summary:

The purpose of this study is to determine whether BMS-986288 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of select advanced solid tumors

  • Condition or Disease:Advanced Cancer
  • Intervention/Treatment: Drug: BMS-986288
    Drug: Nivolumab
  • Phase: Phase 1/Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 200 participants
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Phase 1/2 First-in-human Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Malignant Tumors
  • Actual Study Start Date: July 2019
  • Estimated Primary Completion Date: February 2023
  • Estimated Study Completion Date: February 2024

Arms and interventions

Arm Intervention/treatment
Experimental: Arm A BMS-986288
Specified dose on specified days
Drug: BMS-986288
Specified dose on specified days
Experimental: Arm B BMS-986288 in combination with Nivolumab
Specified dose on specified days
Drug: BMS-986288
Specified dose on specified days

Drug: Nivolumab
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 1. Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), AEs meeting protocol-defined Dose Limiting Toxicities (DLT) Criteria, AEs leading to discontinuation, death and laboratory abnormalities [ Time Frame: Up to 2 years ]
  • Secondary Outcome Measures: 1. Maximum Observed Concentration (Cmax) of BMS-986288 [ Time Frame: Up to 2 years ]
  • 2. Time of Maximum Observed Concentration (Tmax) of BMS-986288 [ Time Frame: Up to 2 years ]
  • 3. Area Under the Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration AUC(0-T) of BMS-986288 [ Time Frame: Up to 2 years ]
  • 4. Area Under the Concentration-Time Curve in one Dosing Interval AUC(TAU) of BMS-986288 [ Time Frame: Up to 2 years ]
  • 5. Observed Concentration at the end of a Dosing Interval (Ctau) of BMS-986288 [ Time Frame: Up to 2 years ]
  • 6. Trough Observed Concentrations (Ctrough) of BMS-986288 [ Time Frame: Up to 2 years ]
  • 7. Total Body Clearance (CLT) of BMS-986288 [ Time Frame: Up to 4 months ]
  • 8. Average Concentration Over a Dosing Interval at Steady State (Cavgss) of BMS-986288 [ Time Frame: Up to 4 months ]
  • 9. Accumulation Index (AI) of BMS-986288 [ Time Frame: Up to 4 months ]
  • 10. Terminal Half-Life (T-HALF) of BMS-986288 [ Time Frame: Up to 4 months ]
  • 11. Incidence of Anti-Drug Antibodies (ADAs) to BMS-986288 [ Time Frame: Up to 2 years ]
  • 12. Objective Response Rate (ORR) of Participants [ Time Frame: Up to 4 years ]
  • 13. Duration of Response (DOR) of Participants [ Time Frame: Up to 4 years ]
  • 14. Progression-Free Survival (PFS) of Participants [ Time Frame: Up to 4 years ]
  • 15. Time to Response (TTR) of Participants [ Time Frame: Up to 4 years ]
  • 16. Percentage of change from baseline in T-regulatory cells (Tregs) [ Time Frame: Up to 2 years ]

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Histologic or cytologic confirmation of select solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease and have at least 1 lesion accessible for biopsy - Eastern Cooperative Oncology Group Performance Status of 0 or 1 - Participants must have received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to select solid tumor histologies Exclusion Criteria: - Participants with active, known or suspected autoimmune disease - Participants with other active malignancy requiring concurrent intervention - Participants with primary CNS malignancies or tumors with CNS metastasis as the only site of disease, will be excluded Other protocol defined inclusion/exclusion criteria could apply

Contacts and Locations

Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations

United States, Colorado
University Of Colorado
Aurora

United States, Maryland
Johns Hopkins University
Baltimore

United States, Missouri
Washington University
Saint Louis

United States, New Jersey
Hackensack University Medical Center
Hackensack

Canada, Ontario
Local Institution
Toronto

Sponsors and Collaborators

Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT03994601 History of Changes
  • Other Study ID Numbers: CA043-001
  • First Posted: June 21, 2019 Key Record Dates
  • Last Update Posted: February 17, 2020
  • Last Verified: February 2020
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No