Clincosm LogoSign in Get a demo

An Investigational Immuno-therapy Study of Experimental Medication BMS-986156, Given by Itself or in Combination With Nivolumab in Patients With Solid Cancers or Cancers That Have Spread.

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT02598960
Collaborator
(none)
331
Enrollment
27
Locations
5
Arms
62.3
Actual Duration (Months)
12.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and tumor-shrinking ability of experimental medication BMS-986156, when given by itself or in combination with nivolumab in patients with solid cancers that are advanced or cancers that have spread.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
331 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1/2a Dose Escalation and Cohort Expansion Study for Safety, Tolerability, and Efficacy of BMS-986156 Administered Alone and in Combination With Nivolumab (BMS-936558, Anti PD-1 Monoclonal Antibody) in Advanced Solid Tumors
Actual Study Start Date :
Oct 9, 2015
Actual Primary Completion Date :
Dec 16, 2020
Actual Study Completion Date :
Dec 16, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: BMS-986156: Dose Escalation

Drug: BMS-986156
Experimental: BMS-986156 + nivolumab (nivo): Dose Escalation

Drug: BMS-986156

Drug: Nivolumab
Experimental: BMS-986156: Dose Expansion

Drug: BMS-986156
Experimental: BMS-986156 + nivolumab (nivo): Dose Expansion

Drug: BMS-986156

Drug: Nivolumab
Experimental: BMS986156 + Nivo: Cohort Expansion

Drug: BMS-986156

Drug: Nivolumab

Outcome Measures

Primary Outcome Measures

  1. Incidence of Adverse Events [Up to 30 days after the last dose of study drug]

  2. Incidence of Serious Adverse Events [Up to 30 days after the last dose of study drug]

  3. Incidence of Adverse Events leading to discontinuation [Up to 30 days after the last dose of study drug]

  4. Incidence of Death [Up to 30 days after the last dose of study drug]

  5. Incidence of Clinical Laboratory Abnormalities [Up to 30 days after the last dose of study drug]

Secondary Outcome Measures

  1. Objective response rate (ORR) [Approximately 3 years]

  2. Progression free survival rate (PFSR) [At week 24]

  3. Duration of response [Approximately 3 years]

  4. Maximum observed concentration (Cmax) of BMS-986156 [Day 1 to 56 days]

  5. Time of maximum observed concentration (Tmax) of BMS-986156 [Day 1 to 56 days]

  6. Area under the concentration-time curve in one dosing interval (AUC [TAU]) of BMS-986156 [Day 1 to 56 days]

  7. Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T) of BMS-986156 [Day 1 to 56 days]

  8. Anti-drug antibody (ADA) response to BMS-986156 [Day 1 to 56 days]

  9. Anti-drug antibody response to BMS-986156 and Nivolumab [Day 1 to 56 days]

  10. Best Overall Response(ORR) [Approximately 3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • For Dose Escalation:

  • Subjects with any previously treated advanced (metastatic or refractory) solid tumor

  • For Cohort Expansion:

  • Subjects must have a previously treated advanced solid tumor to be eligible

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

  • Willing and able to provide pre-treatment and on-treatment fresh tumor biopsy

  • Women of child-bearing potential and men must use an acceptable method of contraception during treatment and for 23 weeks after treatment for women and 31 weeks for men

Exclusion Criteria:

  • Known central nervous system metastases or central nervous system as the only source of disease

  • Other concomitant malignancies (with some exceptions per protocol)

  • Active, known or suspected autoimmune disease

  • Uncontrolled or significant cardiovascular disease

  • History of active or chronic hepatitis (e.g. Hep B or C)

  • Impaired liver or bone marrow function

  • Major surgery less than 1 month before start of the study

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Of Alabama At Birmingham Birmingham Alabama United States 35294-3300
2 UCSD Moores Cancer Center La Jolla California United States 92093-0698
3 Emory University Atlanta Georgia United States 30322
4 The Ohio State University Columbus Ohio United States 43210
5 Providence Portland Medical Center Portland Oregon United States 97213
6 Thomas Jefferson University Hospital Philadelphia Pennsylvania United States 19107
7 The West Clinic, P.C. Germantown Tennessee United States 38138
8 Liverpool Cancer Therapy Center Liverpool New South Wales Australia 2170
9 Local Institution Westmead New South Wales Australia 2145
10 Princess Alexandra Hospital Brisbane Queensland Australia 4102
11 Linear Clinical Research Ltd Nedlands Western Australia Australia 6009
12 Universitair Ziekenhuis Gent Gent Belgium 9000
13 Local Institution Edmonton Alberta Canada T6G 1Z2
14 Local Institution Toronto Ontario Canada M5G 1Z5
15 Local Institution Paris Cedex 5 France 75248
16 Institut Claudius Regaud Toulouse Cedex 9 France 31059
17 Institut Gustave Roussy Vlllejuif France 94800
18 Local Institution Bonn Germany 53127
19 Local Institution Freiburg Germany 79106
20 Local Institution Wuerzburg Germany 97080
21 IRCCS Istituto Nazionale Tumori Milano Milano Italy 20133
22 Istituto Europeo Di Oncologia Milan Italy 20141
23 Local Institution Amsterdam Netherlands 1066CX
24 Local Institution Madrid Spain 28040
25 Local Institution Madrid Spain 28041
26 Cantonal Hospital St. Gallen St. Gallen Switzerland 9007
27 Local Institution Zurich Switzerland 8091

Sponsors and Collaborators

  • Bristol-Myers Squibb

Investigators

  • Study Director: Bristol Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02598960
Other Study ID Numbers:
  • CA009-002
  • 2015-002505-11
First Posted:
Nov 6, 2015
Last Update Posted:
Dec 21, 2020
Last Verified:
Dec 1, 2020
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Nivolumab

Study Results

No Results Posted as of Dec 21, 2020