BMS-986012 in Relapsed/Refractory SCLC

February 9, 2024 updated by: Bristol-Myers Squibb

A Phase 1/2 Multicenter Study of BMS-986012 in Subjects With Relapsed/Refractory Small Cell Lung Cancer

The purpose of this study is to determine the safety, tolerability, pharmacokinetics, immunogenicity, antitumor activity and pharmacodynamics of BMS-986012 alone and in combination with nivolumab in patients with relapsed/refractory SCLC.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
106

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • St. Leonards, New South Wales, Australia, 2065
        • Local Institution - 0020
    • Queensland
      • Brisbane, Queensland, Australia, 4102
        • Local Institution - 0011
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Local Institution - 0002
  • Belgium
      • Gent, Belgium, 9000
        • Local Institution - 0015
      • Liege, Belgium, 4000
        • Local Institution - 0012
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Local Institution - 0003
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Local Institution - 0017
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Local Institution - 0019
      • London, Ontario, Canada, N6A 4L6
        • Local Institution - 0010
      • Toronto, Ontario, Canada, M5G 2M9
        • Local Institution - 0007
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Local Institution - 0008
  • Netherlands
      • Nijmegen, Netherlands, 6525 GA
        • Local Institution - 0013
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Local Institution - 0009
  • United States
    • New York
      • New York, New York, United States, 10065
        • Local Institution - 0004
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Local Institution - 0001
      • Winston-Salem, North Carolina, United States, 27157
        • Local Institution - 0021

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Inclusion Criteria:

  • Histological or cytological confirmed small cell lung cancer (SCLC)
  • Performance Status 0-1
  • Adequate organ function
  • Measurable disease

Exclusion Criteria:

  • Known or suspected brain metastasis
  • Small cell cancer not lung in origin
  • Significant or acute medical illness
  • Uncontrolled or significant cardiac disease
  • Infection
  • ≥ Grade 2 peripheral neuropathy
  • Concomitant malignancies
  • HIV related disease or known or suspected HIV+
  • Hepatitis B or C infection
  • ECG abnormalities as defined by the protocol
  • Allergies or hypersensitivities to monoclonal antibodies, BMS-986012 or related compounds, including fucosyl-GM1 vaccine and Nivolumab

Other protocol defined inclusion/exclusion criteria could apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dose Escalation (Monotherapy) Dose -1
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
Biological: BMS-986012 (anti-fucosyl-GM1)
Experimental: Dose Escalation (Monotherapy) Dose 1
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
Biological: BMS-986012 (anti-fucosyl-GM1)
Experimental: Dose Escalation (Monotherapy) Dose 2
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
Biological: BMS-986012 (anti-fucosyl-GM1)
Experimental: Dose Escalation (Monotherapy) Dose 3
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
Biological: BMS-986012 (anti-fucosyl-GM1)
Experimental: Dose Escalation (Monotherapy) Dose 4
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
Biological: BMS-986012 (anti-fucosyl-GM1)
Experimental: Dose Expansion (Monotherapy)- Cohort A (Refractory)
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
Biological: BMS-986012 (anti-fucosyl-GM1)
Experimental: Dose Expansion (Monotherapy) Cohort B (Refractory)
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
Biological: BMS-986012 (anti-fucosyl-GM1)
Experimental: Dose Expansion (Monotherapy) Cohort C (Sensitive)
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
Biological: BMS-986012 (anti-fucosyl-GM1)
Experimental: Dose Expansion (Monotherapy) Cohort D (Sensitive)
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
Biological: BMS-986012 (anti-fucosyl-GM1)
Experimental: Dose Escalation (Combination) Dose 1
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity in combination with Nivolumab specified dose on specified days
Biological: Nivolumab
Biological: BMS-986012 (anti-fucosyl-GM1)
Experimental: Dose Escalation (Combination) Dose 2
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity in combination with Nivolumab specified dose on specified days
Biological: Nivolumab
Biological: BMS-986012 (anti-fucosyl-GM1)
Experimental: Dose Expansion (Combination)- (Refractory and Sensitive)
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity in combination with Nivolumab specified dose on specified days
Biological: Nivolumab
Biological: BMS-986012 (anti-fucosyl-GM1)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events (AEs)
Time Frame: From first dose to 100 days post last dose (Up to 64 months)
Number of participants with any grade adverse events (AEs). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
From first dose to 100 days post last dose (Up to 64 months)
Number of Participants With Serious Adverse Events (SAEs)
Time Frame: From first dose to 100 days post last dose (Up to 64 months)

Number of participants with any grade serious adverse events (SAEs). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:

  • results in death
  • is life-threatening
  • requires inpatient hospitalization or causes prolongation of existing hospitalization
  • results in persistent or significant disability/incapacity
  • is a congenital anomaly/birth defect
  • is an important medical event Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
From first dose to 100 days post last dose (Up to 64 months)
Number of Participants With Adverse Events (AEs) Leading to Discontinuation
Time Frame: From first dose to 100 days post last dose (Up to 64 months)
Number of participants with any grade adverse events (AEs) leading to discontinuation. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
From first dose to 100 days post last dose (Up to 64 months)
Number of Participants Who Died
Time Frame: From first dose to 100 days post last dose (Up to 64 months)
Number of participants who died due to any cause.
From first dose to 100 days post last dose (Up to 64 months)
Number of Participants With Abnormal Hepatic Test
Time Frame: From first dose to 100 days post last dose (Up to 64 months)

Number of participants with laboratory abnormalities in specific hepatic tests. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized:

  • ALT or AST > 5xULN, > 3xULN, and > 2xULN
  • Any of ALT, AST, Total Bilirubin or ALP > 8xULN
  • Total bilirubin > 3xULN

ALT = Alanine Aminotransferase; AST = Aspartate Aminotransferase; ULN = Upper Limit of Normal
From first dose to 100 days post last dose (Up to 64 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
BMS-986012 Maximum Observed Serum Concentration (Cmax)
Time Frame: Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)
BMS-986012 maximum observed serum concentration (Cmax).
Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)
BMS-986012 Time of Maximum Observed Serum Concentration (Tmax)
Time Frame: Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)
BMS-986012 time of maximum observed serum concentration (Tmax).
Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)
BMS-986012 Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC (0-T))
Time Frame: Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)
BMS-986012 area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC (0-T)).
Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)
BMS-986012 Area Under the Serum Concentration-time Curve in One Dosing Interval AUC (TAU)
Time Frame: Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)
BMS-986012 area under the serum concentration-time curve in one dosing interval AUC (TAU).
Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)
BMS-986012 Observed Serum Concentration at the End of a Dosing Interval (Ctau)
Time Frame: Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)
BMS-986012 observed serum concentration at the end of a dosing interval (Ctau).
Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)
BMS-986012 Total Body Clearance (CLT)
Time Frame: Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)
BMS-986012 total body clearance (CLT).
Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)
BMS-986012 Trough Observed Serum Concentration (Ctrough)
Time Frame: Cycle 2 day 1, cycle 3 day 1, cycle 4 day 1, cycle 7 day 1, cycle 11 day 1. cycle 15 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)
BMS-986012 trough observed serum concentration (Ctrough).
Cycle 2 day 1, cycle 3 day 1, cycle 4 day 1, cycle 7 day 1, cycle 11 day 1. cycle 15 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)
BMS-986012 Average Concentration Over a Dosing Interval (Css-avg)
Time Frame: Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)
BMS-986012 Average concentration over a dosing interval ([AUC(TAU)/tau] (Css-avg).
Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)
BMS-986012 Accumulation Index (AI_AUC)
Time Frame: Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)
BMS-986012 accumulation index. Ratio of an exposure measure at steady state to that after the first dose.
Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)
BMS-986012 Cmax Accumulation Index (AI_Cmax)
Time Frame: Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)
BMS-986012 Cmax accumulation index (AI_Cmax). Ratio of an exposure measure at steady state to that after the first dose.
Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)
BMS-986012 Ctau Accumulation Index (AI_Ctau)
Time Frame: Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)
BMS-986012 Ctau accumulation index (AI_Ctau). Ratio of an exposure measure at steady state to that after the first dose.
Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)
BMS-986012 Effective Elimination (T-HALFeff)
Time Frame: Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)
BMS-986012 effective elimination (T-HALFeff) that explains the degree of accumulation observed for a specific exposure measure.
Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)
Best Overall Response (BOR)
Time Frame: From first dose to the last tumor assessment prior to subsequent therapy (Up to 97 months)
BOR defined as the best response designation over the study as a whole. Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR) = At least a 30% decrease in the sum of diameters of target lesions; Stable Disease (SD) = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Progressive Disease (PD) = At least a 20% increase in the sum of diameters of target lesions and the sum must demonstrate an absolute increase of at least 5 mm
From first dose to the last tumor assessment prior to subsequent therapy (Up to 97 months)
Objective Response Rate (ORR)
Time Frame: From first dose date to the date of first documented disease progression (Up to 97 months)
ORR is defined as the percent of participants whose BOR is either CR or PR. Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR) = At least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD) = At least a 20% increase in the sum of diameters of target lesions and the sum must demonstrate an absolute increase of at least 5 mm
From first dose date to the date of first documented disease progression (Up to 97 months)
Duration of Response (DoR)
Time Frame: From the date of first dose to the date of the first documented tumor progression or death due to any cause, whichever occurs first (Up to 97 months)

DoR is defined as the time from first response (CR or PR) to the date of the first documented tumor progression as determined using RECIST 1.1 criteria or death due to any cause, whichever occurs first. Participants who remain alive and have not progressed will be censored on the date of their last tumor assessment.

Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR )= At least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD) = At least a 20% increase in the sum of diameters of target lesions and the sum must demonstrate an absolute increase of at least 5 mm

Median DOR will only be evaluated provided there are enough responding participants to warrant inclusion.
From the date of first dose to the date of the first documented tumor progression or death due to any cause, whichever occurs first (Up to 97 months)
Progression Free Survival (PFS)
Time Frame: From first dose to the date of first documented disease progression or death due to any cause, if death occurred within 100 days after last BMS-986012 dose (Up to 97 months)

PFS is defined as the time from the date of first dose of study medication to the date of the first objective documentation of tumor progression or death due to any cause, if death occurred within 100 days after last BMS-986012 dose.

Progressive Disease (PD) = At least a 20% increase in the sum of diameters of target lesions and the sum must demonstrate an absolute increase of at least 5 mm
From first dose to the date of first documented disease progression or death due to any cause, if death occurred within 100 days after last BMS-986012 dose (Up to 97 months)
Progression Free Survival Rate (PFSR)
Time Frame: Weeks 12, 24, 36, 48, 60, 72

PFSR is defined as the percent of participants who remain progression free and surviving at "t" weeks (t= 12, 24, 36, 48, 60, 72).

Progressive Disease (PD)=At least a 20% increase in the sum of diameters of target lesions and the sum must demonstrate an absolute increase of at least 5 mm
Weeks 12, 24, 36, 48, 60, 72
Number of Participants With Anti-BMS-986012 Antibodies (ADA)
Time Frame: From first dose to 100 days following the last BMS-986012 dose (Up to 64 months)
Number of participants with anti-BMS-986012 antibodies (ADA) with status as baseline ADA positive, ADA positive and ADA negative. Baseline ADA positive participant is a participant with baseline ADA positive sample (Day 1 predose). ADA-positive participant is a participant with at least one ADA positive sample relative to baseline at any time after initiation of treatment during the defined observation time period. ADA negative participant is a participant with no ADA positive sample after the initiation of treatment.
From first dose to 100 days following the last BMS-986012 dose (Up to 64 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 14, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 21, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 22, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 19, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2014

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA001-030
  • 2014-002372-89 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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