Multiple Regimens for Metastatic Pancreatic Cancer

Recruiting at 25 trial locations

Overseen By Herbert Zeh

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Pancreatic Cancer Action Network

Must not be taking: Immunosuppressives, Myelosuppressives

Disqualifiers: Tuberculosis, Active infections, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

502 Participants Needed

Trial Summary

What is the purpose of this trial?

Precision Promise is a multi-center, seamless Phase 2/3 platform trial designed to evaluate multiple regimens in metastatic pancreatic cancer. Primary Objectives * To compare each investigational arm versus standard of care (SOC) for superiority in overall survival in first and/or second line metastatic ductal adenocarcinoma (metastatic pancreatic cancer) participants and determine which, if any, participants benefit from each investigational arm. Secondary Objectives * To determine short and long-term safety signals of each investigational arm in metastatic pancreatic cancer participants vs. SOC. * To determine progression-free survival (PFS) for each investigational arm vs. SOC. * To determine rates of overall response, CR, and PR; duration of overall response, CR or PR (whichever occurs first). * To determine rates of clinical benefit; duration of clinical benefit.

Eligibility Criteria

Adults over 18 with metastatic pancreatic ductal adenocarcinoma, including several subtypes but excluding neuroendocrine tumors. Participants must be able to swallow pills and adhere to the study schedule, have no severe concurrent diseases or second active cancers, and not be pregnant. They should have acceptable organ function and performance status, agree to provide tissue samples, and can't have had recent major surgery or cancer treatment.

Inclusion Criteria

I have another cancer, but it won't affect this treatment's safety or results.

I am not pregnant and will avoid pregnancy or use birth control during the study.

My blood counts and organ functions are within the required ranges.

Exclusion Criteria

I stopped my pancreatic cancer treatment because of severe side effects.

I haven't had any cancer treatments in the last 21 days or 5 half-lives, whichever is shorter.

I haven't had any live vaccines in the last 30 days, except for the COVID-19 vaccine.

Treatment Details

Interventions

• Canakinumab and Spartalizumab
• Dose -mFOLFIRINOX
• Gemcitabine
• Pamrevlumab
• SM-88

Trial Overview The trial is testing multiple treatments against standard care for advanced pancreatic cancer: mFOLFIRINOX; Gemcitabine with nab-paclitaxel; Pamrevlumab combined with these two drugs; Canakinumab and Spartalizumab also combined with them; plus an experimental drug called SM-88. It aims to find out which improves survival best.

Participant Groups

Group I: pamrevlumab (FibroGen) Experimental Treatment 1 Intervention

Arm is closed to recruitment. Experimental: Pamrevlumab in combination with gemcitabine/nab-paclitaxel. Participants enrolled to this treatment arm will receive treatment with pamrevlumab in combination with gemcitabine and nab-paclitaxel. Gemcitabine and nab-paclitaxel are FDA approved therapies for metastatic pancreatic cancer and will be supplied or obtained according to local clinical study agreements and in accordance with local guidelines.

Group II: Experimental: SM-88 Experimental Treatment 1 Intervention

Arm is closed to recruitment. 460 mg (2 capsules) twice daily of a 28-day cycle along with the administration of methoxsalen, phenytoin and sirolimus. All four agents (SM-88, methoxsalen, phenytoin, and sirolimus) should be dosed with approximately 240 mL (8 fl. oz.) of water in the morning. All four agents should be taken together consistently. SM-88 used with MPS should ideally be taken approximately 1 hour before or 2 hours after a meal.

Group III: Canakinumab and Spartalizumab Experimental Treatment 1 Intervention

Arm is closed to recruitment. Canakinumab and Spartalizumab in Combination with Nab-Paclitaxel and Gemcitabine. Participants enrolled to this treatment arm will receive treatment with Canakinumab and Spartalizumab in combination with nab-paclitaxel and gemcitabine.

Group IV: Gemcitabine combined with nab-paclitaxel Active Control 1 Intervention

Arm is closed to recruitment. The following are recommended parameters for infusion timing and sequence, although institutional variation in the administration of the regimen are permitted as long as drug dosing and modification guidelines are followed.

Group V: mFOLFIRINOX Active Control 1 Intervention

Arm is closed to recruitment. Oxaliplatin 85 mg/m2, Leucovorin 400 mg/m2, Irinotecan 150 mg/m2, 5-Fluorouracil 2400 mg/m2 46-48 hour infusion

Who Is Running the Clinical Trial?

Pancreatic Cancer Action Network

Lead Sponsor

Trials

6

Recruited

10,000+