Clinical trialPhase 1 / Phase 2Terminated
Safety and Efficacy Study of Ulocuplumab and Nivolumab in Subjects With Solid Tumors
A Phase 1/2 Study of the Safety and Efficacy of Ulocuplumab Combined With Nivolumab in Subjects With Advanced or Metastatic Solid Tumors
- Outcome
- Stopped earlyTrial terminated because of lack of efficacy in the short term acute phase (Efficacy or futility)
- Phase
- Phase 1 / Phase 2
- Status
- Terminated
- Study type
- Interventional
- Start
- 13 July 2015
- Expected end
- 27 January 2017
- Enrollment
- 61 participants
- Sites
- 7
- Primary outcomes
- Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Immune-mediated AEs; Objective Response Rate (ORR) Per RECIST 1.1 Criteria; Overall Survival (OS); Number of Participants With Laboratory Abnormalities; Number of Participants With Electrocardiogram Abnormalities
- Sponsor
- Industry
- Results posted
- 2018-03-29
- Last update
- 1 November 2018
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Brief summary public domain (ClinicalTrials.gov)
The purpose of this study is to determine whether the combination of Ulocuplumab and Nivolumab is safe and effective in the treatment of pancreatic cancer and small cell lung cancer.
Detailed description public domain (ClinicalTrials.gov)
* Intervention model: Single group for Stage 1 DLT, then Parallel * Data Monitoring Committee: No (Stage 1) Yes (Stage 2 Randomized Ph2)
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Immune-mediated AEs [From first dose until date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2017, approximately 18 months)]. Number, Participants. Adverse Events: PAC DL1 (DLT) (n=6): 6; PAC DL-1 (Tot) (n=27): 27; SCLC (Tot) (n=8): 8. Serious Adverse Events: PAC DL1 (DLT) (n=6): 3; PAC DL-1 (Tot) (n=27): 21; SCLC (Tot) (n=8): 7. Immune-mediated AEs: PAC DL1 (DLT) (n=6): 1; PAC DL-1 (Tot) (n=27): 3.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Objective Response Rate (ORR) Per RECIST 1.1 Criteria [From first dose until disease progression or treatment discontinuation (assessed up to January 2017, approximately 18 months)]. Number, Percentage of participants (90% Confidence Interval). PAC DL1 (DLT) (n=6): 0 (0 to 39.3); PAC DL-1 (Tot) (n=27): 0 (0 to 10.5).
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Overall Survival (OS) [From date of randomization to date of death (assessed up to study completion, approximately 18 months)].
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Number of Participants With Laboratory Abnormalities [From first dose until date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2017, approximately 18 months)]. Number, Participants. Increased lymphocytes: PAC DL1 (DLT) (n=6): 1; PAC DL-1 (Tot) (n=27): 2. Decreased platelet count: PAC DL1 (DLT) (n=6): 1; PAC DL-1 (Tot) (n=27): 2. Hemoglobin: PAC DL1 (DLT) (n=6): 1; PAC DL-1 (Tot) (n=27): 1. Leukocytes: PAC DL1 (DLT) (n=6): 0; PAC DL-1 (Tot) (n=27): 1. Neutrophils: PAC DL1 (DLT) (n=6): 0; PAC DL-1 (Tot) (n=27): 0. Platelet Count: PAC DL1 (DLT) (n=6): 1; PAC DL-1 (Tot) (n=27): 2. Alanine Aminotransferase: PAC DL1 (DLT) (n=6): 0; PAC DL-1 (Tot) (n=27): 3. Alkaline Phosphatase: PAC DL1 (DLT) (n=6): 1; PAC DL-1 (Tot) (n=27): 11. Aspartate Aminotransferase: PAC DL1 (DLT) (n=6): 0; PAC DL-1 (Tot) (n=27): 5. Bilirubin: PAC DL1 (DLT) (n=6): 0; PAC DL-1 (Tot) (n=27): 1. Creatine: PAC DL1 (DLT) (n=6): 0; PAC DL-1 (Tot) (n=27): 0. Hypernatremia: PAC DL1 (DLT) (n=6): 0; PAC DL-1 (Tot) (n=27): 0. Hyponatremia: PAC DL1 (DLT) (n=6): 1; PAC DL-1 (Tot) (n=27): 3. Hypermagnesemia: PAC DL1 (DLT) (n=6): 0; PAC DL-1 (Tot) (n=27): 0. Hypomagnesemia: PAC DL1 (DLT) (n=6): 0; PAC DL-1 (Tot) (n=27): 0. Hypercalcemia: PAC DL1 (DLT) (n=6): 0; PAC DL-1 (Tot) (n=27): 0. Hypocalcemia: PAC DL1 (DLT) (n=6): 0; PAC DL-1 (Tot) (n=27): 0. Hyperkalemia: PAC DL1 (DLT) (n=6): 0; PAC DL-1 (Tot) (n=27): 1. Hypokalemia: PAC DL1 (DLT) (n=6): 0; PAC DL-1 (Tot) (n=27): 0. Amylase: PAC DL1 (DLT) (n=6): 1; PAC DL-1 (Tot) (n=27): 0. Lipase: PAC DL1 (DLT) (n=6): 1; PAC DL-1 (Tot) (n=27): 1.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression-Free Survival (PFS) [From first dose to date of progression (assessed up to January 2017, approximately 18 months)].
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Number of Participants With Electrocardiogram Abnormalities [From first dose to date of last dose plus 30 days].