A Phase I Study to Evaluate Different Immunotherapy and Chemotherapy Combinations for Previously Untreated Metastatic Pancreatic Cancer

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Full Title

A Multicenter, Open-label, ExploRatory Platform Trial to EValuate ImmunOtherapy Combinations with Chemotherapy for the Treatment of Patients with PreviousLy UnTreated MetastatIc Pancreatic AdenOcarciNoma (REVOLUTION) (WIRB)

Purpose

This study is assessing the safety and preliminary effectiveness of different combinations of immunotherapy and chemotherapy drugs in people with metastatic pancreatic cancer that has not yet been treated. Participants in this study will receive one of these combinations:

  • The chemotherapy drugs gemcitabine and nab-paclitaxel with the immunotherapy drugs ipilimumab and nivolumab, OR
  • The chemotherapy drugs gemcitabine and nab-paclitaxel with the immunotherapy drug ipilimumab and the anti-malaria drug hydroxychloroquine.

Ipilimumab and nivolumab take the brakes off the immune response, enabling the immune system to find and kill cancer cells. Hydroxychloroquine manipulates an immune response in the cells of the body and may slow cancer growth. It is taken orally (by mouth) and the other medications in this study are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic pancreatic adenocarcinoma.
  • No prior treatment may have been given for metastatic disease. However, participants who previously received therapy for nonmetastatic pancreatic adenocarcinoma are eligible if their treatment was completed more than 4 months before receiving the study treatment.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for people age 18 and older.For more information about this study and to inquire about eligibility, please contact Dr. Eileen O’Reilly at 646-888-4182.

For more information about this study and to inquire about eligibility, please contact Dr. Eileen O’Reilly at 646-888-4182.

Protocol

21-284

Phase

I

Disease Status

Newly Diagnosed

Investigator

Co-Investigators