Trial record 1 of 1 for:
CA224-048
An Investigational Study of Immunotherapy Combinations in Participants With Solid Cancers That Are Advanced or Have Spread
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03459222 |
|
Recruitment Status :
Recruiting
First Posted : March 8, 2018
Last Update Posted : October 22, 2020
|
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
The purpose of this study is to investigate safety and anti-tumor activity of relatlimab combination therapy in solid cancers that are advanced or have spread
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Advanced Cancer | Biological: Relatlimab Biological: Nivolumab Drug: BMS-986205 Biological: Ipilimumab | Phase 1 Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 230 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 1/2 Study of Relatlimab (Anti-LAG-3 Monoclonal Antibody) Administered in Combination With Both Nivolumab (Anti-PD-1 Monoclonal Antibody) and BMS-986205 (IDO1 Inhibitor) or in Combination With Both Nivolumab and Ipilimumab (Anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors |
| Actual Study Start Date : | May 25, 2018 |
| Estimated Primary Completion Date : | February 1, 2023 |
| Estimated Study Completion Date : | February 1, 2023 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Arm A
Relatlimab + Nivolumab + BMS-986205
|
Biological: Relatlimab
Specified dose on specified days
Other Name: BMS-986016 Biological: Nivolumab Specified dose on specified days
Other Names:
Drug: BMS-986205 Specified dose on specified days |
|
Experimental: Arm B
Relatlimab + Nivolumab + Ipilimumab
|
Biological: Relatlimab
Specified dose on specified days
Other Name: BMS-986016 Biological: Nivolumab Specified dose on specified days
Other Names:
Biological: Ipilimumab Specified dose on specified days
Other Names:
|
Primary Outcome Measures :
- Number of clinical laboratory test abnormalities [ Time Frame: approximately 4 years ]
- Number of Adverse Events (AEs) [ Time Frame: approximately 4 years ]
- Number of Serious Adverse Events (SAEs) [ Time Frame: approximately 4 years ]
- Number of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria [ Time Frame: Up to 6 weeks ]
- Number of AEs leading to discontinuation and deaths [ Time Frame: approximately 4 years ]
- Objective Response Rate (ORR) [ Time Frame: approximately 4 years ]
- Disease Control Rate (DCR) [ Time Frame: approximately 4 years ]
- Median Duration of Response (mDOR) [ Time Frame: approximately 4 years ]
Secondary Outcome Measures :
- Progression Free Survival (PFS) [ Time Frame: up to 4 years ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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 an incurable solid malignancy that is advanced (metastatic and/or unresectable), with measurable disease per RECIST v1.1
- Available tumor tissue for biomarker analysis
- Eastern Cooperative Oncology Group Performance Status (ECOG) status of 0 or 1
Exclusion Criteria:
- Participants with known or suspected uncontrolled CNS metastases or with the CNS as the only site of active disease
- Participants with a history of interstitial lung disease (ILD) / pneumonitis
- Prior malignancy active within the previous 3 years except for locally curable cancers that have been cured, such as basal or squamous cell skin cancer
Other protocol defined inclusion/exclusion criteria could apply
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03459222
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
Show 20 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT03459222 |
| Other Study ID Numbers: |
CA224-048 2018-000058-22 ( EudraCT Number ) |
| First Posted: | March 8, 2018 Key Record Dates |
| Last Update Posted: | October 22, 2020 |
| Last Verified: | October 2020 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Bristol-Myers Squibb:
|
immunotherapy Relatlimab |
Additional relevant MeSH terms:
|
Nivolumab Ipilimumab Antineoplastic Agents, Immunological Antineoplastic Agents |