Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Skin and Connective Tissue Diseases

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma, Non-Small-Cell Lung

Breast Neoplasms

Lung Neoplasms

Pancreatic Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

Pancreatic Cancer

All Drugs and Chemicals

Antineoplastic Agents

Immunomodulating Agents

Nivolumab

Daratumumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

TNBC and PAC participants who are deriving clinical benefit will continue to be treated with the nivolumab plus daratumumab combination therapy

NSCLC patients who are deriving clinical benefit will be treated with nivolumab monotherapy

Bristol-Myers Squibb

The purpose of this study is to determine whether a combination of Nivolumab and Daratumumab is safe and effective when treating Pancreatic, Non-Small Cell Lung or Triple Negative Breast Cancers, that have advanced or have spread.

A Study to Test the Safety and Effectiveness of Nivolumab Combined With Daratumumab in Patients With Pancreatic, Non-Small Cell Lung or Triple Negative Breast Cancers, That Have Advanced or Have Spread

Phase 1/2 Study to Evaluate the Safety and Preliminary Efficacy of Nivolumab Combined With Daratumumab in Participants With Advanced or Metastatic Solid Tumors

Number of participants with any grade of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Daratumumab

Number of participants with any grade of serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Daratumumab

Number of participants with laboratory abnormalities in specific liver tests based on US conventional units to determine the safety and tolerability of Nivolumab and Daratumumab. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized:

* ALT or AST \> 3 x ULN, \> 5 x ULN, \> 10 x ULN and \> 20 x ULN
* Total bilirubin \> 2 x ULN
* ALP \> 1.5 x ULN
* Concurrent (within 1 day) ALT or AST \> 3 x ULN and total bilirubin \> 1.5 x ULN
* Concurrent (within 30 days) ALT or AST \> 3 x ULN and total bilirubin \> 1.5 x ULN
* Concurrent (within 1 day) ALT or AST \> 3 x ULN and total bilirubin \> 2 x ULN
* Concurrent (within 30 days) ALT or AST \> 3 x ULN and total bilirubin \> 2 x ULN

Number of participants with laboratory abnormalities in specific thyroid tests based on US conventional units to determine the safety and tolerability of Nivolumab and Daratumumab. The number of subjects with the following laboratory abnormalities from on-treatment evaluations will be summarized:

* TSH value \> ULN and
* with baseline TSH value \<= ULN
* with at least one FT3/FT4 test value \< LLN within 2-week window after the abnormal TSH test
* with all FT3/FT4 test values \>= LLN within 2-week window after the abnormal TSH test
* with FT3/FT4 missing within 2-week window after the abnormal TSH test.
* TSH \< LLN and
* with baseline TSH value \>= LLN
* with at least one FT3/FT4 test value \> ULN within 2-week window after the abnormal TSH test
* with all FT3/FT4 test values \<= ULN within 2-week window after the abnormal TSH test
* with FT3/FT4 missing within 2-week window after the abnormal TSH test

Number of participants with laboratory test results of worst (CTC v4.0) grades 0-4 to determine the safety and tolerability of Nivolumab and Daratumumab

Objective response rate (ORR) is defined as the percentage of treated participants who achieve a best response of complete response (CR) or partial response (PR) based on investigator assessments (using RECIST v1.1 criteria)

Duration of response (DOR) is defined as the time between the date of first documented response (Complete response or partial response) to the date of the first documented tumor progression as determined by Investigator (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first

Best overall response (BOR) is defined as the best response, as determined by Investigator, recorded between the date of first dose and the date of objectively documented progression per RECIST v1.1 criteria or the date of subsequent therapy, whichever occurs first.

Progression Free Survival (PFS) is defined as the time between the date of treatment start day and the date of first documented tumor progression, based on Investigator assessments (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first.

Pharmacokinetics (PK) assessed using serum concentration data for Nivolumab

Pharmacokinetics (PK) assessed using serum concentration data for Daratumumab

Percentage of participants Anti Drug Antibody (ADA) to assess immunogenicity by ADA positive status and ADA negative status, relative to baseline. ADA positive is a participant with at least one ADA-positive sample relative to baseline (ADA negative at baseline or ADA titer to be at least 4-fold or greater (\>=) than baseline positive titer) at any time after initiation of treatment. ADA Negative is a participant with no ADA-positive sample after initiation of treatment

Janssen Biotech, Inc.

Triple-negative breast cancer (TNBC) treated with Triple-negative breast cancer (TNBC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)

Nivolumab + Daratumumab (TNBC)

Non-small cell lung cancer (NSCLC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)

Nivolumab + Daratumumab (NSCLC)

Pancreatic adenocarcinoma cancer (PAC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)

Nivolumab + Daratumumab (PAC)

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

American Indian or Alaska Native

Asian

Native Hawaiian or Other Pacific Islander

Black or African American

White

Other

Race/Ethnicity, Customized

Bristol-Myers Squibb Study Director

Number of Participants With Adverse Events (AEs)

Number of Participants With Serious Adverse Events (SAEs)

ALT OR AST > 3XULN

ALT OR AST > 5XULN

ALT OR AST > 10XULN

ALT OR AST > 20XULN

TOTAL BILIRUBIN > 2XULN

ALP > 1.5XULN

CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN > 1.5XULN WITHIN ONE DAY

CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN > 1.5XULN WITHIN 30 DAYS

CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN > 2XULN WITHIN ONE DAY

CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN > 2XULN WITHIN 30 DAYS

All treated participants with at least one on-treatment measurement of the corresponding laboratory parameter

Number of Participants With Laboratory Abnormalities in Specific Liver Tests

TSH > ULN

TSH > ULN WITH TSH <= ULN AT BASELINE

TSH > ULN WITH AT LEAST ONE FT3/FT4 TEST VALUE < LLN

TSH > ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN

TSH > ULN WITH FT3/FT4 TEST MISSING

TSH < LLN

TSH < LLN WITH TSH >= LLN AT BASELINE

TSH < LLN WITH AT LEAST ONE FT3/FT4 TEST VALUE > ULN

TSH < LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN

TSH < LLN WITH FT3/FT4 TEST MISSING

All treated participants with at least one on-treatment TSH measurement

Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests

Objective Response Rate (ORR)

All treated participants with objective response

Duration of Response (DOR)

Complete Response (CR)

Partial Response (PR)

Stable Disease (SD)

Progressive Disease (PD)

Unable to Determine (UTD)

Best Overall Response (BOR)

Progression Free Survival (PFS)

Cycle 3 Day 1

Cycle 4 Day 1

Cycle 7 Day 1

Cycle 11 Day 1

Follow-up 1

Follow-up 2

Nivolumab (NSCLC)

Nivolumab (PAC)

Nivolumab Serum Concentrations

Cycle 1 Day 1 (hour 8)

Cycle 2 Day 1 (hour 0)

Cycle 2 Day 1 (hour 4)

Cycle 3 day 1

Cycle 4 day 1

Cycle 7 day 1

Daratumumab (NSCLC)

Daratumumab (PAC)

Daratumumab Serum Concentrations

Nivolumab Baseline ADA Positive

Daratumumab Baseline ADA Positive

Nivolumab ADA Positive

Nivolumab ADA Negative

Daratumumab ADA Positive

Daratumumab ADA Negative

Percentage of Participants Anti Drug Antibody (ADA) by Positivity

Hemoglobin

Platelet Count

Leukocytes

Alkaline Phosphatase

Aspartate Aminotransferase

Alanine Aminotransferase

Bilirubin

Creatinine

Phosphorous

Albumin

Amylase

Lipase

Hypernatremia

Hyponatremia

Hyperkalemia

Hypokalemia

Hypercalcemia

Hypocalcemia

Hypermagnesemia

Hypomagnesemia

Hyperglycemia

Hypoglycemia

Number of Participants With Laboratory Results of Worst CTC Grade

Overall Study

Spots Global Cancer Trial Database for A Study to Test the Safety and Effectiveness of Nivolumab Combined With Daratumumab in Patients With Pancreatic, Non-Small Cell Lung or Triple Negative Breast Cancers, That Have Advanced or Have Spread

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial