NCT04377048

Nivolumab Adding on Gemcitabine/S-1 in Metastatic Pancreatic Cancer

Status unknown Phase 2 Last updated 6 May 2020

What this trial tests

Phase 2 trial testing Nivolumab in Stage IV Pancreatic Cancer in 38 participants. Status unknown.

Timeline

1 July 2020

Primary endpoint
1 July 2022

31 December 2022

Quick facts

Lead sponsor	National Taiwan University Hospital
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	38
Start date	1 July 2020
Primary completion	1 July 2022
Estimated completion	31 December 2022

Drugs / interventions tested

• Nivolumab (nivolumab) — full drug profile →
• Gemcitabine (gemcitabine) — full drug profile →
• Tegafur-Gimeracil-Oteracil

Conditions studied

• Stage IV Pancreatic Cancer — all drugs for Stage IV Pancreatic Cancer →

Sponsor

National Taiwan University Hospital

Who can join

Adults 20 to 75, any sex, with Stage IV Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study assumes that to achieve significant therapeutic efficacy in advanced pancreatic cancer with immunotherapy, the immune system must remain relatively intact. Therefore, early use, low tumor load, adequate organ function, and slow growth of the tumor are the key points. Stage IV pancreatic adenocarcinoma patients with limited metastatic lesions and adequate organ function will be enrolled. Gemcitabine plus S-1 (GS) will be administered initially, and then CA 19-9 will be evaluated. Those fulfilling pre-defined criteria of CA 19-9 will receive nivolumab add-on therapy.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Immunotherapy in Pancreatic Cancer: Why Do We Keep Failing? A Focus on Tumor Immune Microenvironment, Predictive Biomarkers and Treatment Outcomes.
   Di Federico A, Mosca M, Pagani R, Carloni R, et al · · 2022 · cited 82× · PMID 35626033 · DOI 10.3390/cancers14102429
2. Hacking Pancreatic Cancer: Present and Future of Personalized Medicine.
   Di Federico A, Tateo V, Parisi C, Formica F, et al · · 2021 · cited 48× · PMID 34358103 · DOI 10.3390/ph14070677
3. Challenges and Future Perspectives of Immunotherapy in Pancreatic Cancer.
   Wandmacher AM, Letsch A, Sebens S. · · 2021 · cited 20× · PMID 34439389 · DOI 10.3390/cancers13164235
4. Clinical and Pre-Clinical Evidence of Carbonic Anhydrase IX in Pancreatic Cancer and Its High Expression in Pre-Cancerous Lesions.
   Strapcova S, Takacova M, Csaderova L, Martinelli P, et al · · 2020 · cited 20× · PMID 32707920 · DOI 10.3390/cancers12082005
5. Immunotherapy and Pancreatic Cancer: A Lost Challenge?
   Laface C, Memeo R, Maselli FM, Santoro AN, et al · · 2023 · cited 18× · PMID 37511856 · DOI 10.3390/life13071482
6. Biological Hallmarks and New Therapeutic Approaches for the Treatment of PDAC.
   Digiacomo G, Volta F, Garajova I, Balsano R, et al · · 2021 · cited 16× · PMID 34440587 · DOI 10.3390/life11080843
7. Negative prognostic implications of splenomegaly in nivolumab-treated advanced or recurrent pancreatic adenocarcinoma.
   Yang SH, Lu LC, Kao HF, Chen BB, et al · · 2021 · cited 12× · PMID 34595057 · DOI 10.1080/2162402x.2021.1973710
8. Adding-on nivolumab to chemotherapy-stabilized patients is associated with improved survival in advanced pancreatic ductal adenocarcinoma.
   Yang SH, Kuo SH, Lee JC, Chen BB, et al · · 2024 · cited 6× · PMID 39249118 · DOI 10.1007/s00262-024-03821-3