Pancreatic Cancer Research

Clinical trialPhase 1 / Phase 2Completed

A Study of Nivolumab by Itself or Nivolumab Combined With Ipilimumab in Patients With Advanced or Metastatic Solid Tumors

A Phase 1/2, Open-label Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab in Subjects With Advanced or Metastatic Solid Tumors

NCT01928394↗ ClinicalTrials.gov, retrieved 6 November 2026

Outcome
Outcome unknown
Phase
Phase 1 / Phase 2
Status
Completed
Study type
Interventional
Start
24 October 2013
Expected end
18 November 2024
Enrollment
1,163 participants
Sites
38
Primary outcomes
Objective Response Rate ( ORR )
Sponsor
Industry
Results posted
2020-03-24
Last update
27 December 2024

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Brief summary public domain (ClinicalTrials.gov)

To investigate the safety and efficacy of nivolumab as a single agent or in combination with ipilimumab in 6 tumor types - triple-negative breast cancer (TNBC), gastric cancer (GC), pancreatic adenocarcinoma (PC), small cell lung cancer (SCLC), bladder cancer (BC), and ovarian cancer (OC). A combination of nivolumab with ipilimumab and cobimetinib is also investigated in PC.

Detailed description public domain (ClinicalTrials.gov)

All tumor types are now closed for enrollment: Triple Negative Breast Cancer Gastric Cancer Pancreatic Cancer Small Cell Lung Cancer Bladder Cancer Ovarian Cancer

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Objective Response Rate ( ORR ) [60 months]. Number, Percentage of Participants (95% Confidence Interval). TNBC Arm N (n=18): 5.6 (0.1 to 27.3); TNBC Arm N-I Dose Level 1 (n=3): 0.0 (0.0 to 70.8); TNBC Arm N-I Dose Level 2 (n=18): 0.0 (0.0 to 18.5); GC Arm N (n=59): 11.9 (4.9 to 22.9); GC Arm N-I Dose Level 1 (n=3): 0.0 (0.0 to 70.8); GC Arm N-I Dose Level 2 (n=49): 24.5 (13.3 to 38.9); GC Arm N-I Dose Level 2b (n=52): 7.7 (2.1 to 18.5); PC Arm N (n=18): 0.0 (0 to 18.5); PC Arm N-I Dose Level 1 (n=3): 0.0 (0.0 to 70.8); PC Arm N-I Dose Level 2 (n=18): 0.0 (0.0 to 18.5); PC Arm N-I Dose Level 2d (n=30): 6.7 (0.8 to 22.1); SCLC Arm N - Pre-expansion (n=98): 13.3 (7.3 to 21.6); SCLC Arm N-I Dose Level 2 - Pre-expansion (n=61): 26.2 (15.8 to 39.1); SCLC Arm N Expansion (n=147): 11.6 (6.9 to 17.9); SCLC Arm N-I Dose Level 2- Expansion (n=96): 21.9 (14.1 to 31.5); SCLC Arm N-I Dose Level 1 - (n=3): 33.3 (0.8 to 90.6); SCLC Arm N-I Dose Level 2b (n=55): 18.2 (9.1 to 30.9); SCLC Arm N- All Treated (n=245): 11.8 (8.1 to 16.6); SCLC Arm N-I Dose Level 2 - All Treated (n=157): 22.3 (16.0 to 29.6); BC Arm N (n=78): 25.6 (16.4 to 36.8); BC Arm N-I Dose Level 2 (n=92): 38.0 (28.1 to 48.8); BC Arm N-I Dose Level 2b (n=104): 26.9 (18.7 to 36.5); OC Arm N-I Dose Level 2 (n=41): 12.2 (4.1 to 26.2); OC Arm N-I Dose Level 2b: (n=43): 7.0 (1.5 to 19.1); OC Arm N-I Dose Level 2c: (n=42): 9.5 (2.7 to 22.6). Analysis, SCLC Arm N Expansion vs SCLC Arm N-I Dose Level 2- Expansion: Odds Ratio (OR) 2.12 (95% CI 1.06 to 4.26); p=0.0309; Cochran-Mantel-Haenszel; superiority.

Papers 5