Trial record 1 of 1 for:
CA022-001
First-In-Human Study of Monoclonal Antibody BMS-986218 by Itself and in Combination With Nivolumab in Patients With Advanced Solid Tumors
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| ClinicalTrials.gov Identifier: NCT03110107 |
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Recruitment Status :
Recruiting
First Posted : April 12, 2017
Last Update Posted : November 4, 2020
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Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
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Brief Summary:
The purpose of this study is to determine whether a Monoclonal Antibody both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Advanced Cancer | Biological: Ipilimumab Biological: BMS-986218 Biological: Nivolumab | Phase 1 Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 366 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase 1/2a First-In-Human Study of BMS-986218 Monoclonal Antibody Alone and in Combination With Nivolumab in Advanced Solid Tumors |
| Actual Study Start Date : | April 28, 2017 |
| Estimated Primary Completion Date : | November 3, 2023 |
| Estimated Study Completion Date : | November 3, 2023 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| Experimental: Ipilimumab Monotherapy |
Biological: Ipilimumab
Specified dose on specified days
Other Name: Yervoy |
| Experimental: Combination Therapy |
Biological: BMS-986218
Specified dose on specified days Biological: Nivolumab Specified dose on specified days
Other Name: Opdivo |
| Experimental: BMS-986218 Monotherapy |
Biological: BMS-986218
Specified dose on specified days |
Primary Outcome Measures :
- Incidence of Adverse Events (AEs) [ Time Frame: Up to 4 years ]
- Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 4 years ]
- Objective Response Rate (ORR) of BMS-986218 monotherapy relative to Ipilimumab in immuno-oncology (IO) progressed melanoma cohort [ Time Frame: Up to 4 years ]
- Median Duration of Response (mDOR) of BMS-986218 monotherapy relative to Ipilimumab in IO progressed melanoma cohort [ Time Frame: Up to 4 years ]
- Progression Free Survival (PFS) of BMS-986218 monotherapy relative to Ipilimumab in IO progressed melanoma cohort [ Time Frame: Up to 4 years ]
- Incidence of AEs meeting protocol- defined DLT criteria [ Time Frame: Up to 4 years ]
- Incidence of AEs leading to discontinuation [ Time Frame: Up to 4 years ]
- Incidence of death [ Time Frame: up to 4 years ]
- Incidence of laboratory abnomalities [ Time Frame: Up to 4 years ]
Secondary Outcome Measures :
- ORR of BMS-986218 alone or in combination with Nivolumab [ Time Frame: Up to 4 years ]
- mDOR of BMS-986218 alone or in combination with Nivolumab [ Time Frame: Up to 4 years ]
- PFS of BMS-986218 alone or in combination with Nivolumab [ Time Frame: Up to 4 years ]
- Incidence of anti-drug antibody (ADA) to BMS-986218 [ Time Frame: Up to 4 years ]
- Percentage of change from baseline in T-regulatory cells (Tregs) [ Time Frame: Up to 4 years ]
- Maximum observed serum concentration (Cmax) [ Time Frame: Up to 4 years ]
- Time of maximum observed concentration (Tmax) [ Time Frame: Up to 4 years ]
- Area under the concentration-time curve from time zero to the time of the [ Time Frame: Up to 4 years ]
- Area under the concentration-time curve in 1 dosing interval [AUC(TAU)] [ Time Frame: Up to 4 years ]
- Trough observed serum concentration (Ctrough) [ Time Frame: Up to 4 years ]
- Total body clearance (CLT) [ Time Frame: Up to 4 years ]
- Average serum concentration over a dosing interval (AUC[TAU]/tau) at steady state (Css-avg) [ Time Frame: Up to 4 years ]
- Ratio of an exposure measure at steady state to that after the first dose [exposure measure includes AUC[TAU] and Cmax (AI)] [ Time Frame: Up to 4 years ]
- Terminal serum half-life if data permit (T-HALF) [ Time Frame: Up to 4 years ]
- Observed concentration at the end of a dosing interval (Ctau) [ Time Frame: Up to 4 years ]
- Time to deterioration (TTD) in Quality of Life and physical functioning [ Time Frame: Up to 4 years ]
Information from the National Library of Medicine
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| 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 a solid tumor that is advanced (metastatic, recurrent and/or unresectable)
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Participants must have received, and then progressed, relapsed, or been intolerant to at least 2 standard treatment regimens with proven survival benefit in the advanced or metastatic setting according to tumor type, if such a therapy exists
Exclusion Criteria:
- Participants with primary CNS malignancies, or tumors with CNS metastases as the only site of disease, will be excluded
- Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy
- Prior anti-cancer treatments such as chemotherapy, radiotherapy, hormonal, or immunotherapy (including anti-PD-1/PD-L1) are permitted
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): NCT03110107
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 54 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: | NCT03110107 |
| Other Study ID Numbers: |
CA022-001 2017-000597-11 ( EudraCT Number ) |
| First Posted: | April 12, 2017 Key Record Dates |
| Last Update Posted: | November 4, 2020 |
| Last Verified: | November 2020 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Nivolumab Ipilimumab Antineoplastic Agents, Immunological Antineoplastic Agents |