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A Study of BMS-986148 in Patients With Select Advanced Solid Tumors
This study is ongoing, but not recruiting participants.
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02341625
First received: January 14, 2015
Last updated: June 30, 2017
Last verified: June 2017
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Purpose
The purpose of this study is to determine the safety, tolerability, pharmacokinetics, immunogenicity, antitumor activity and pharmacodynamics of BMS-986148 administered alone and in combination with nivolumab in patients with mesothelioma, non-small cell lung cancer, ovarian cancer, pancreatic cancer and gastric cancer.
| Condition | Intervention | Phase |
|---|---|---|
| Advanced Cancer | Drug: BMS-986148 Biological: Nivolumab | Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: No masking Primary Purpose: Treatment |
| Official Title: | A Phase I/IIa Study of BMS-986148, a Mesothelin Directed Antibody Drug Conjugate, in Subjects With Select Advanced Solid Tumors |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Safety is measured by incidence of adverse events (AEs) at its worst grade, serious adverse events (SAEs) at its worst grade, adverse events leading to discontinuations, deaths, frequency of laboratory test toxicity grade shifting from baseline [ Time Frame: Approximately 5 years ]
Secondary Outcome Measures:
- Maximum observed serum or plasma concentration (Cmax) of BMS-986148 [ Time Frame: Day 1 through day 21 and day 66 through day 87 ]
- Time of maximum observed serum or plasma concentration (Tmax) of BMS-986148 [ Time Frame: Day 1 through day 21 and day 66 through day 87 ]
- Concentration at the end of a dosing interval (Ctau) of BMS-986148 [ Time Frame: Day 1 through day 21 and day 66 through day 87 ]
- Trough observed serum or plasma concentration (this includes pre-dose concentrations and Ctau concentrations) (Ctrough) of BMS-986148 [ Time Frame: Day 1 through day 21 and day 66 through day 87 ]
- Area under the concentration-time curve from time 0 to time t (AUC(0-t)) of BMS-986148 (t= t last) [ Time Frame: Day 1 through day 21 and day 66 through day 87 ]
- Area under the concentration-time curve in one dosing interval (AUC(TAU)) of BMS-986148 [ Time Frame: Day 1 through day 21 and day 66 through day 87 ]
- Terminal serum or plasma half-life (T-Half) of BMS-986148 [ Time Frame: Day 1 through day 21 and day 66 through day 87 ]
- Total body clearance calculated as Dose divided by AUC(TAU) (CLT) of BMS-986148 [ Time Frame: Day 1 through day 21 and day 66 through day 87 ]
- Volume of distribution at steady-state (Vss) of BMS-986148 [ Time Frame: Day 1 through day 21 and day 66 through day 87 ]
- Volume of distribution of terminal phase (Vz) of BMS-986148 [ Time Frame: Day 1 through day 21 and day 66 through day 87 ]
- Accumulation index; ratio of Cmax at steady-state to Cmax after the first dose (AI_Cmax) of BMS-986148 [ Time Frame: Day 1 through day 21 and day 66 through day 87 ]
- Accumulation index; ratio of Ctau at steady-state to Ctau after the first dose (AI_Ctau) of BMS-986148 [ Time Frame: Day 1 through day 21 and day 66 through day 87 ]
- Average concentration over a dosing interval calculated by dividing AUC(TAU) by tau (Cavg) of BMS-986148 [ Time Frame: Day 1 through day 21 and day 66 through day 87 ]
- Best overall response (BOR) of BMS-986148 [ Time Frame: Approximately 5 years ]Best overall response (BOR): defined as the best response designation over the study as a whole, recorded between the dates of first dose until the last tumor assessment prior to subsequent therapy
- Objective Response rate (ORR) [ Time Frame: Approximately 5 years ]Objective Response Rate (ORR): defined as the total number of patients whose best overall response (BOR) is either a Complete Response (CR) or Partical Response (PR) divided by the total number of patients in the population of interest
- Duration of response [ Time Frame: Approximately 5 years ]Duration of Response: defined as the time between the date of first response and the subsequent date of objectively documented disease progression or death, whichever occurs first
- Progression free survival [ Time Frame: Approximately 5 years ]Duration of Response: defined as the time between the date of first response and the subsequent date of objectively documented disease progression or death, whichever occurs first
- Progression free survival rate [ Time Frame: Approximately 5 years ]Progression Free Survival Rate (PFSR) at week 't': defined as the proportion of patients who remain progression free and surviving at 't' weeks (t=12, 24, 36, etc)
- Overall survival [ Time Frame: Approximately 5 years ]Overall Survival (OS): defined as the time between the date of first dose of study medication and the date of death
- Overall survival rate [ Time Frame: Approximately 5 years ]Overall Survival Rate (OSR) at month 't': defined as the probability of patients surviving at 't' months (eg, t=6, 12, 24 months, etc)
- Changes in QTcF of BMS-986148 [ Time Frame: Day 1 through day 7 and day 66 through day 73 ]
- Immunogenicity of BMS-986148 [ Time Frame: Day 1 through day 100 ]Immunogenicity as measured by positive Anti-drug antibody (ADA)
| Estimated Enrollment: | 407 |
| Actual Study Start Date: | June 17, 2015 |
| Estimated Study Completion Date: | August 29, 2022 |
| Estimated Primary Completion Date: | June 14, 2021 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Part 1: Ascending dose of BMS-986148
BMS-986148 Intravenous injection at increasing doses on specific days until the maximum tolerated dose is reached. Five cancers will be studied in this part: mesothelioma, pancreatic, ovarian, gastric, and non-small cell lung cancer. Alternate dose and schedules may be explored.
|
Drug: BMS-986148 |
|
Experimental: Part 2: Expansion dose of BMS-986148
BMS-986148 Intravenous injection of Maximum tolerated dose (MTD) on specific days. Five cancers will be studied in this part: mesothelioma, pancreatic, ovarian, gastric, and non-small cell lung cancer.
|
Drug: BMS-986148 |
|
Experimental: Part 3A: Ascending dose of BMS-986148
Set dose of nivolumab and BMS-986148 intravenous injection at increasing doses on specific days until the maximum tolerated dose is reached. Five cancers will be studied in this part: mesothelioma, pancreatic, ovarian, gastric, and non-small cell lung cancer.
|
Drug: BMS-986148
Biological: Nivolumab
Other Name: Opdivo
|
|
Experimental: Part 3B: Expansion dose of BMS-986148
Set dose of nivolumab and BMS-986148 intravenous injection at or below maximum tolerated dose on specific days. Five cancers will be studied in this part: mesothelioma, pancreatic, ovarian, gastric, and non-small cell lung cancer.
|
Drug: BMS-986148
Biological: Nivolumab
Other Name: Opdivo
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- Must have pancreatic, ovarian, gastric, non-small cell cancer or mesothelioma. For dose expansion, must have tumor that is positive for mesothelin
- Expected to have life expectancy of at least 3 months
- Men and women 18 years old or older (or local age of majority)
- Must have measurable tumor per Response Evaluation Criteria In Solid Tumors (RECIST) or modified RECIST for malignant pleural mesothelioma
- ECOG of 0 to 1
Exclusion Criteria:
- Cancer metastases in the brain
- Moderate eye disorders
- Active infection or past hepatitis B or C infection
- Major surgery less than 1 month before the start of the study
- Uncontrolled heart disease
- Impaired liver or bone marrow function
- History of allergy to mesothelin-directed antibodies, tubulysin, monoclonal antibodies, nivolumab or related compounds
Contacts and Locations
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02341625
Please refer to this study by its ClinicalTrials.gov identifier: NCT02341625
Locations
| United States, California | |
| UC San Diego Moores Cancer Ctr | |
| La Jolla, California, United States, 92093-0698 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| Australia, New South Wales | |
| Local Institution | |
| Liverpool, New South Wales, Australia, 2170 | |
| Australia, South Australia | |
| Local Institution | |
| Adelaide, South Australia, Australia, 5000 | |
| Australia, Victoria | |
| Local Institution | |
| Clayton, Victoria, Australia, 3168 | |
| Australia, Western Australia | |
| Local Institution | |
| Nedlands, Western Australia, Australia, 6009 | |
| Belgium | |
| Local Institution | |
| Gent, East Flanders, Belgium, 9000 | |
| Local Institution | |
| Bruxelles, Belgium, 1200 | |
| Canada, Alberta | |
| Cross Cancer Institute | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Canada, Ontario | |
| Princess Margaret Cancer Centre | |
| Toronto, Ontario, Canada, M5G 1Z5 | |
| Italy | |
| Local Institution | |
| Milano, Italy, 20133 | |
| Istituto Europeo Di Oncologia | |
| Milano, Italy, 20141 | |
| Istituto Clinico Humanitas | |
| Rozzano (milano), Italy, 20089 | |
| Netherlands | |
| Local Institution | |
| Amsterdam, Netherlands, 1066 CX | |
| Local Institution | |
| Rotterdam, Netherlands, 3075 EA | |
| United Kingdom | |
| Local Institution | |
| Southampton, Hampshire, United Kingdom, SO16 6YD | |
| Local Institution | |
| Glasgow, Lanarkshire, United Kingdom, G12 0YN | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT02341625 History of Changes |
| Other Study ID Numbers: |
CA008-002 2014-002485-70 ( EudraCT Number ) |
| Study First Received: | January 14, 2015 |
| Last Updated: | June 30, 2017 |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Additional relevant MeSH terms:
|
Nivolumab Antineoplastic Agents |
ClinicalTrials.gov processed this record on July 11, 2017