Advanced CancerPhase 1/2NCT02341625
A Study of BMS-986148 in Patients With Select Advanced Solid Tumors
A Phase 1/2 study testing BMS-986148 and Nivolumab in people with Advanced Cancer, run by Bristol-Myers Squibb at 17 sites in 7 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- BMS-986148 and Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 17 sitesin 7 countries
- Study dates
- 19 Jun 2015to 7 May 2020
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
17 sites in 7 countries.
17 sites in 7 countries
Australia4 sites
Local Institution - 0014
Adelaide, South Australia, 5000
Local Institution - 0004
Clayton, Victoria, 3168
Local Institution - 0013
Liverpool, New South Wales, 2170
Local Institution - 0015
Nedlands, Western Australia, 6009
Italy3 sites
Local Institution - 0017
Milan, Lombardy, 20141
Local Institution - 0018
Milan, 20133
Local Institution - 0016
Rozzano (milano), 20089
United States2 sites
Duke University Medical Center
Durham, North Carolina, 27710
Moores Cancer Center
La Jolla, California, 92093-0698
Belgium2 sites
Local Institution - 0009
Brussels, 1200
Local Institution - 0008
Ghent, Oost-Vlaanderen, 9000
Canada2 sites
Local Institution - 0002
Edmonton, Alberta, T6G 1Z2
Local Institution - 0003
Toronto, Ontario, M5G 1Z5
Netherlands2 sites
Local Institution - 0010
Amsterdam, 1066 CX
Local Institution - 0011
Rotterdam, 3015 AA
United Kingdom2 sites
Local Institution - 0006
Glasgow, Lanarkshire, G12 0YN
Local Institution - 0007
Southampton, Hampshire, SO16 6YD
About this study
Official title: A Phase I/IIa Study of BMS-986148, a Mesothelin Directed Antibody Drug Conjugate, in Subjects With Select Advanced Solid Tumors
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.
- Conditions
- Advanced Cancer
- Being tested
- BMS-986148, Nivolumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986148Drug
NivolumabBiological
Also called Opdivo
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Ascending dose of BMS-986148 | Experimental | 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. Receives: Drug: BMS-986148 |
| Part 2: Expansion dose of BMS-986148 | Experimental | 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. Receives: Drug: BMS-986148 |
| Part 3A: Ascending dose of BMS-986148 | Experimental | 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. Receives: Drug: BMS-986148; Biological: Nivolumab |
| Part 3B: Expansion dose of BMS-986148 | Experimental | 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. Receives: Drug: BMS-986148; Biological: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events at Worst CTC Grade
Number of participants with adverse events at worst CTC grade including any grade adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuations, and deaths grouped by dose + dose regimen.
Measured: From first dose to up to 100 days post last dose (Up to 6 months)
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline
Number of participants with laboratory test toxicity grade (Grade 0, 1, 2, 3, and 4) in hematology and chemistry shifting from baseline. An increase in baseline indicates a shift of participant to a greater toxicity grade. A decrease in baseline indicates a shift of participant to a lesser toxicity grade. Participants are grouped by dose + dose regimen assessed by NCT CTCAE V 4.03.
Measured: From first dose to up to 100 days post last dose (Up to 6 months)
Secondary outcomes (13)
Maximum Observed Serum Concentration (Cmax)
Maximum observed serum concentration (Cmax) of BMS-986148 grouped by dose + dose regimen.
Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.
Measured: PK blood assessed on cycle 1, day 1
Time of Maximum Observed Serum Concentration (Tmax)
Time of maximum observed serum concentration (Tmax) of BMS-986148 grouped by dose + dose regimen.
Measured: PK blood assessed on cycle 1, day 1
Concentration at the End of a Dosing Interval (Ctau)
Concentration at the end of a dosing interval (Ctau) of BMS-986148 grouped by dose + dose regimen.
Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.
Measured: PK blood assessed on cycle 1, day 1
Trough Observed Serum Concentration (Ctrough)
Trough observed serum concentration (Ctrough) of BMS-986148 grouped by dose + dose regimen.
Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.
Measured: PK blood assessment include cycle 2-day 1 and cycle 1-day 8
Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t))
Area under the concentration-time curve from time Zero to time T (AUC(0-t)) of BMS-986148 grouped by dose + dose regimen.
Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.
Measured: PK blood assessment include cycle 1-day 1
Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU])
Area under the concentration-time curve in one dosing interval (AUC[TAU]) of BMS-986148 grouped by dose + dose regimen Note: The geometric CV was not calculated. Arithmetic % CV is reported instead
Measured: PK blood assessment include cycle 1-day 1
Best Overall Response (BOR)
Best overall response is 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.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The sum must also demonstrate an absolute increase of at least 5 mm.
Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Measured: Up to 58 months
Objective Response Rate (ORR)
Objective response rate is defined as the total percentage of participants whose best overall response (BOR) is either a complete response or partial response divided by the total percentage of participants who are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung (NSCL), and Gastric).
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: Up to 58 months
Duration of Response (DoR)
Duration of response is defined as the time between the date of first response and the subsequent date of objectively documented disease progression or death, whichever occurs first. Participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung (NSCL), and Gastric).
Measured: Up to 58 months
Progression Free Survival (PFS)
Progression Free Survival is defined as the time from the first dose of study medication to the date of the first objective documentation of tumor progression or death due to any cause. Progression is defined with at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm. Participants who did not progress nor died will be censored on the date of their last tumor assessment. Participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung (NSCL), and Gastric).
Measured: Up to 58 months
Progression Free Survival Rate (PFSR) at Week t
Progression free survival rate is defined as the proportion of participants who remain progression free and surviving at 't' weeks (t=4-12 months). The proportion will be calculated by the product-limit method (Kaplan-Meier estimate) which takes into account censored data. Participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung (NSCL), and Gastric).
Measured: Total PFS assessed between 4 and 12 months, PFSR at months 4 and 6 to be reported
Changes in QT Corrected by the Fridericia Formula (QTcF) From Baseline, at Selected Times
Changes of participants in QT corrected by the fridericia formula (QTcF) Interval from baseline at <= 30 msec, >30 - <= 60 msec, and > 60 msec grouped by dose + dose regimen
Measured: Up to 58 months
Number of Participants With Anti-Drug Antibody (ADA)
Number of participants with anti-drug antibody (ADA) status grouped by dose + dose regimen.
Data was not collected for this outcome measure.
Measured: Up to 58 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study start19 Jun 2015
- Primary completion25 Feb 2019
- Study completion7 May 2020
Why it stopped: Study terminated for business reasons not related to safety.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02341625
- Sponsor's protocol ID
- CA008-002
- Other IDs
- 2014-002485-70, 2014
- Status last verified
- Jul 2022
- First submitted
- 14 Jan 2015
- Last updated
- 18 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Rottey S, Clarke J, Aung K, Machiels JP, Markman B, Heinhuis KM, Millward M, Lolkema M, Patel SP, de Souza P, Duca M, Curigliano G, Santoro A, Koyama T, Brown M, Vezina H, He C, Chu QS. Phase I/IIa Trial of BMS-986148, an Anti-mesothelin Antibody-drug Conjugate, Alone or in Combination with Nivolumab in Patients with Advanced Solid Tumors. Clin Cancer Res. 2022 Jan 1;28(1):95-105. doi: 10.1158/1078-0432.CCR-21-1181. Epub 2021 Oct 6.
PubMed 34615718
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Study of BMS-986148, a Mesothelin Directed Antibody Drug Conjugate, in Subjects With Select Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02341625
- Acronym / sponsor ID
- CA008-002
- Conditions
- Advanced Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated for business reasons not related to safety.
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2015 (actual)
- Primary completion
- 25 Feb 2019 (actual)
- Study completion
- 7 May 2020 (actual)
- First posted
- 19 Jan 2015 (estimated)
- Results
- Posted 18 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1: Ascending dose of BMS-986148 | Experimental | Drug: BMS-986148BMS-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. |
| Part 2: Expansion dose of BMS-986148 | Experimental | Drug: BMS-986148BMS-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. |
| Part 3A: Ascending dose of BMS-986148 | Experimental | Drug: BMS-986148, Biological: NivolumabSet 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. |
| Part 3B: Expansion dose of BMS-986148 | Experimental | Drug: BMS-986148, Biological: NivolumabSet 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-986148 | Drug | Part 1: Ascending dose of BMS-986148, Part 2: Expansion dose of BMS-986148, Part 3A: Ascending dose of BMS-986148, Part 3B: Expansion dose of BMS-986148 |
| NivolumabAlso: Opdivo | Biological | Part 3A: Ascending dose of BMS-986148, Part 3B: Expansion dose of BMS-986148 |
Primary outcome
Number of Participants With Adverse Events at Worst CTC Grade
Time frame: From first dose to up to 100 days post last dose (Up to 6 months)
Number of participants with adverse events at worst CTC grade including any grade adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuations, and deaths grouped by dose + dose regimen.
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline
Time frame: From first dose to up to 100 days post last dose (Up to 6 months)
Number of participants with laboratory test toxicity grade (Grade 0, 1, 2, 3, and 4) in hematology and chemistry shifting from baseline. An increase in baseline indicates a shift of participant to a greater toxicity grade. A decrease in baseline indicates a shift of participant to a lesser toxicity grade. Participants are grouped by dose + dose regimen assessed by NCT CTCAE V 4.03.
13 secondary outcomes
Maximum Observed Serum Concentration (Cmax)
Time frame: PK blood assessed on cycle 1, day 1
Time of Maximum Observed Serum Concentration (Tmax)
Time frame: PK blood assessed on cycle 1, day 1
Concentration at the End of a Dosing Interval (Ctau)
Time frame: PK blood assessed on cycle 1, day 1
Trough Observed Serum Concentration (Ctrough)
Time frame: PK blood assessment include cycle 2-day 1 and cycle 1-day 8
Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t))
Time frame: PK blood assessment include cycle 1-day 1
Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU])
Time frame: PK blood assessment include cycle 1-day 1
Best Overall Response (BOR)
Time frame: Up to 58 months
Objective Response Rate (ORR)
Time frame: Up to 58 months
Duration of Response (DoR)
Time frame: Up to 58 months
Progression Free Survival (PFS)
Time frame: Up to 58 months
Progression Free Survival Rate (PFSR) at Week t
Time frame: Total PFS assessed between 4 and 12 months, PFSR at months 4 and 6 to be reported
Changes in QT Corrected by the Fridericia Formula (QTcF) From Baseline, at Selected Times
Time frame: Up to 58 months
Number of Participants With Anti-Drug Antibody (ADA)
Time frame: Up to 58 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34615718Rottey S, Clarke J, Aung K, Machiels JP, Markman B, Heinhuis KM, Millward M, Lolkema M, Patel SP, de Souza P, Duca M, Curigliano G, Santoro A, Koyama T, Brown M, Vezina H, He C, Chu QS. Phase I/IIa Trial of BMS-986148, an Anti-mesothelin Antibody-drug Conjugate, Alone or in Combination with Nivolumab in Patients with Advanced Solid Tumors. Clin Cancer Res. 2022 Jan 1;28(1):95-105. doi: 10.1158/1078-0432.CCR-21-1181. Epub 2021 Oct 6.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Investigator Inquiry FormLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
17 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BMS-986148 and Nivolumab in people with Advanced Cancer, run by Bristol-Myers Squibb at 17 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Australia, Italy, United States, Belgium, Canada and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events at Worst CTC Grade (time frame: From first dose to up to 100 days post last dose (Up to 6 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02341625, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2022.