← Back to Search

Monoclonal Antibodies

Multiple Regimens for Metastatic Pancreatic Cancer

Phase 3

Waitlist Available

Research Sponsored by Pancreatic Cancer Action Network

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate organ function including absolute neutrophil count ≥ 1500/mm3, hemoglobin ≥ the lower limit of normal (LLN) or 9g/dL, platelets ≥ 100,000/mm3, serum creatinine ≤ 1.0 x upper limit normal (ULN) or calculated creatinine clearance ≥ 50 mL/min (Cockcroft Gault), albumin ≥ 3.0 g/dL, aspartate aminotransferase (AST) serum glutamic oxaloacetic transaminase (SGOT) and/or alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) ≤ 2.5 x ULN (up to ≤ 5 x ULN in presence of liver metastasis), total bilirubin ≤ 1.5 x ULN, INR ≤ 1.5 x ULN (up to ≤ 2 x ULN for participants on anticoagulation therapy).

No known leptomeningeal disease.

Must not have

Participants that discontinued previous treatment for pancreatic adenocarcinoma due to a treatment-related ≥ Grade 3 toxicity.

Known active tuberculosis infection.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from screening through study completion, an average of 2 years.

Awards & highlights

Approved for 10 Other Conditions

No Placebo-Only Group

Pivotal Trial

Summary

This trial is designed to compare multiple investigational regimens against standard of care in metastatic pancreatic cancer patients, in order to determine which, if any, patients benefit from each investigational arm. Secondary objectives include determining short- and long-term safety signals of each investigational arm, as well as progression-free survival and response rates.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include reactions from chemotherapy like nausea, fatigue, hair loss, blood cell count changes leading to increased infection risk or bleeding problems. Immunotherapy may cause immune system-related inflammation affecting various organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

I do not have cancer that has spread to the lining of my brain and spinal cord.

Select...

I have a specific type of advanced pancreatic cancer and haven't started or only had one treatment.

Select...

I can swallow pills, capsules, or tablets.

Select...

My heart function is good enough for daily activities without severe symptoms.

Select...

I am fully active or have some restrictions but can still take care of myself.

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I have an active tuberculosis infection.

Select...

I have a history of lung conditions like sarcoidosis or pulmonary fibrosis.

Select...

I have an autoimmune disease like lupus or Hashimoto's.

Select...

I do not have any ongoing infections that are not improving with treatment.

Select...

I have not had major surgery in the last 2 weeks.

Select...

I do not have severe nerve damage in my hands or feet.

Select...

I cannot swallow pills, capsules, or tablets.

Select...

I am not allergic to any of the study drugs or their ingredients.

Select...

I have not had an organ or bone marrow transplant from another person.

Select...

I have a serious wound, ulcer, or bone fracture that is not healing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from screening through study completion, an average of 2 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from screening through study completion, an average of 2 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening through study completion, an average of 2 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival

Secondary study objectives

Duration of Clinical Benefit

Duration of Overall Response Rate (ORR)

Overall Response Rate (ORR)

+2 more

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: pamrevlumab (FibroGen)Experimental Treatment1 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-88Experimental Treatment1 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 SpartalizumabExperimental Treatment1 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-paclitaxelActive Control1 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: mFOLFIRINOXActive Control1 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

0 / 18Eligibility criteria met