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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening through study completion, an average of 2 years.
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My blood counts and organ functions are within the required ranges.
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I do not have cancer that has spread to the lining of my brain and spinal cord.
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I have a specific type of advanced pancreatic cancer and haven't started or only had one treatment.
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I can swallow pills, capsules, or tablets.
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My heart function is good enough for daily activities without severe symptoms.
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I am fully active or have some restrictions but can still take care of myself.
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I am 18 years old or older.
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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival
Secondary outcome measures
Duration of Clinical Benefit
Duration of Overall Response Rate (ORR)
Overall Response Rate (ORR)
+2 moreTrial 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
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
Oxaliplatin 85 mg/m2, Leucovorin 400 mg/m2, Irinotecan 150 mg/m2, 5-Fluorouracil 2400 mg/m2 46-48 hour infusion
Find a Location
Who is running the clinical trial?
Pancreatic Cancer Action NetworkLead Sponsor
5 Previous Clinical Trials
12,636 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I have an active tuberculosis infection.I am not on strong immune or bone marrow suppressing drugs, except for low-dose prednisone.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.I have a history of lung conditions like sarcoidosis or pulmonary fibrosis.I have an autoimmune disease like lupus or Hashimoto's.I do not have cancer that has spread to the lining of my brain and spinal cord.I have a specific type of advanced pancreatic cancer and haven't started or only had one treatment.I do not have any ongoing infections that are not improving with treatment.I can swallow pills, capsules, or tablets.I have not had major surgery in the last 2 weeks.I do not have severe nerve damage in my hands or feet.I cannot swallow pills, capsules, or tablets.I am not on treatment for another cancer that could affect this study.I am not allergic to any of the study drugs or their ingredients.My cancer can be measured on scans and was checked within the last 28 days.My heart function is good enough for daily activities without severe symptoms.My brain metastases are stable, and any related symptoms have improved or gone back to normal.I have not had an organ or bone marrow transplant from another person.I have a serious wound, ulcer, or bone fracture that is not healing.I do not have severe heart problems like recent heart attacks or uncontrolled heart rhythm issues.Your heart takes longer than a certain amount of time to recharge between beats.I have hepatitis B but my latest test showed no virus.I am fully active or have some restrictions but can still take care of myself.I am HIV-positive, on treatment, and my last viral load test was negative.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Gemcitabine combined with nab-paclitaxel
- Group 2: mFOLFIRINOX
- Group 3: pamrevlumab (FibroGen)
- Group 4: Canakinumab and Spartalizumab
- Group 5: Experimental: SM-88
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the most common type of cancer that Dose- Canakinumab and Spartalizumab combined with nab-paclitaxel and gemcitabine are used to treat?
"The recommended dosage for canakinumab, spartalizumab, nab-paclitaxel, and gemcitabine is when treating neoplasm metastasis. However, this novel cocktail of drugs can also be used to ameliorate symptoms of locally advanced non-small cell lung cancer, metastatic bladder cancer, and urinary bladder conditions."
Answered by AI
Are there any documented cases of adverse effects from using Dose- Canakinumab and Spartalizumab combined with nab-paclitaxel and gemcitabine?
"Dose- Canakinumab and Spartalizumab in combination with nab-paclitaxel and gemcitabine is considered safe by our team at Power. This Phase 3 trial has data supporting the efficacy of this drug as well as multiple rounds of data that support safety."
Answered by AI
Are there any available slots for patients who wish to enroll in this clinical trial?
"The clinical trial is currently seeking participants and was last edited on 8/18/2022. The study was initially posted on 1/31/2020 and is looking for 825 individuals at 22 locations."
Answered by AI
Is this research being conducted at a lot of places in North America?
"22 medical centres are currently recruiting patients for this trial. While some of these locations are in Albuquerque, Baltimore and La Jolla, other sites are located throughout the country. To reduce the amount of travel required, please select the clinical trial site that is closest to your location."
Answered by AI
Have there been any other medical trials that have tested a combination of Dose- Canakinumab and Spartalizumab with nab-paclitaxel and gemcitabine?
"There are 1168 ongoing studies worldwide that focus on Dose- Canakinumab and Spartalizumab in combination with nab-paclitaxel and gemcitabine. Out of these, 332 are in Phase 3. The majority of research locations for this treatment are based in Shanghai, but 59923 other centres across the globe are running similar trials."
Answered by AI
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