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

Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

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

ClinicalTrials.gov ID

NCT03098550

Acronym / sponsor ID

CA209-9GW

Conditions

Advanced Cancer

Keywords

Non-small cell lung cancer (NSCLC), Triple Negative Breast Cancer (TNBC), Pancreatic Cancer (PAC)

Phase

Phase 1/2

Study type

Interventional

Recruitment status

Completed

Enrolment

105 participants (actual)

Lead sponsor

Bristol-Myers SquibbIndustry (pharma, biotech, devices)

Collaborators

Janssen Biotech, Inc.

Study start

15 Jun 2017 (actual)

Primary completion

6 Jul 2020 (actual)

Study completion

6 Jul 2020 (actual)

First posted

31 Mar 2017 (actual)

Results

Posted 23 Jul 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Not applicable

Intervention model

Single group

Masking

None (open label)

Number of arms

2

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Number of Participants With Adverse Events (AEs)

   Time frame: From first dose to 30 days post last dose (up to 34 months)

   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

2. Number of Participants With Serious Adverse Events (SAEs)

   Time frame: From first dose to 30 days post last dose (up to 34 months)

   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

3. Number of Participants With Laboratory Abnormalities in Specific Liver Tests

   Time frame: From first dose to 30 days post last dose (up to 34 months)

   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

4. Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests

   Time frame: From first dose to 30 days post last dose (up to 34 months)

   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

5. Number of Participants With Laboratory Results of Worst CTC Grade

   Time frame: From first dose to 30 days post last dose (up to 34 months)

   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

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• BMS Clinical Trial InformationLink provided by the sponsor.
• BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
• FDA Safety Alerts and RecallsLink provided by the sponsor.
• Individual participant dataSharing planned: No

Related trials for Advanced Cancer

• Enrolling by invitationPhase 2

  A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer

  Pancreatic Cancer Metastatic

• RecruitingPhase 1/2

  Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)

  Solid Tumor, Non-Small Cell Lung Cancer

• Active, not recruitingPhase 3

  A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)

  Carcinoma, Renal Cell

• RecruitingPhase 3

  A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)

  Non-Small Cell Lung Cancer (NSCLC)

• Active, not recruitingPhase 1

  A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor

  Neoplasms

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.

20 sites in 9 countries: see every site and its status.