Clinical trial NCT03363776: An Investigational Immuno-Therapy Study of Experimental Medication BMS-986277 Given Alone and in Combination With Nivolumab in Epithelial Cancers
Official title: Phase 1/2a First in Human Study of BMS-986277 Administered Alone and in Combination With Nivolumab in Advanced Epithelial Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-12-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate experimental medication BMS-986277 given alone and in combination with Nivolumab in patients with epithelial cancers.


Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Histological or cytological confirmation of metastatic and/or unresectable metastatic colorectal, prostate, pancreatic, breast, ovarian, or urothelial carcinoma with measureable disease for solid tumors per RECIST v1.1 and for prostate carcinoma per PCWG3
* Presence of at least 2 lesions: at least one with measurable disease as defined by RECIST v1.1 for solid tumors and by PCWG3 for prostate carcinoma for response assessment; at least 1 lesion must be accessible for biopsy in addition to the target lesion
* Participants must have received, and then progressed or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting, if such a therapy exists, and have been considered for all other potentially efficacious therapies prior to enrollment
* ECOG performance status less than or equal to 2

Exclusion Criteria:

* Participants with active central nervous system (CNS) metastases, untreated CNS metastases, or with the CNS as the only site of disease
* Participants with carcinomatous meningitis
* Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study treatment
* Participants with active, known, or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Number of Participants With an Adverse Event (AE)
timeFrame: from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)
measure: Number of Participants With a Serious Adverse Event (SAE)
timeFrame: from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)
measure: Number of Participants With an Adverse Event (AE) Meeting Protocol-defined Dose Limiting Toxicity (DLT) Criteria
timeFrame: from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)
measure: Number of Participants With an Adverse Event (AE) Leading to Discontinuation
timeFrame: from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)
measure: Number of Participants With an Adverse Event (AE) Leading to Death
timeFrame: from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)
measure: Number of Participants With a Clinical Laboratory Test Abnormality
timeFrame: from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)
measure: Number of Participants With a Vital Sign Abnormality or Other Safety Biomarkers
timeFrame: from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: at Weeks 8, 16 and 24
measure: Disease Control Rate (DCR)
timeFrame: at Weeks 8, 16 and 24
measure: Median Duration of Response (mDOR)
timeFrame: at Weeks 8, 16 and 24
measure: Median Progression-Free Survival (mPFS)
timeFrame: at Weeks 8, 16 and 24, to progression
measure: Progression-Free Survival Rate (PFSR)
timeFrame: at Weeks 8, 16 and 24
measure: Cmax
timeFrame: Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
measure: Tmax
timeFrame: Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
measure: AUC(0-T)
timeFrame: Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
measure: AUC(INF)
timeFrame: Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
measure: T-HALF
timeFrame: Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
measure: CLT
timeFrame: Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
measure: Vss
timeFrame: Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
measure: Vz
timeFrame: Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
measure: AUC(0-48)
timeFrame: Cycle 1 (from time zero to 48 hours postdose)
measure: AUC(0-8)
timeFrame: Cycle 1 (from time zero to 8 hours postdose)
measure: C48
timeFrame: Cycle 1 at 48 hours postdose
measure: Css-avg
timeFrame: Cycle 1 (from time zero to 48 hours postdose)
measure: AI_AUC
timeFrame: Cycle 1 (Day 19, Day 15)
measure: AI_Cmax
timeFrame: Cycle 1 (Day 19, Day 15)
measure: T-HALFeff
timeFrame: Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
measure: Ctrough
timeFrame: Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
measure: Number of Participants With a Positive Antibody-Drug-Antibody (ADA) Response
timeFrame: Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
Other outcomes:
Locations:
city: Sioux Falls
country: United States
facility: Sanford Research
state: South Dakota
city: Ottawa
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: