Multiple Regimens for Metastatic Pancreatic Cancer

No longer recruiting at 26 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

Duration: Up to 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the most effective treatment options for individuals with metastatic pancreatic cancer, particularly those who haven't responded to other treatments. Researchers are testing several drug combinations, including Canakinumab and Spartalizumab (types of immunotherapy), to determine if they can extend patients' lives and enhance their quality of life compared to standard treatment. They are also monitoring for side effects and assessing how well the cancer responds to these treatments. Individuals with confirmed metastatic pancreatic ductal adenocarcinoma (a type of pancreatic cancer that has spread) and measurable disease may be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering patients access to potentially groundbreaking treatments.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you cannot have received any anti-cancer systemic therapy within 21 days before joining the trial. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that the treatments being tested have promising safety records.

For the combination of Canakinumab and Spartalizumab, research indicates that this treatment is generally safe and well-tolerated by patients with advanced pancreatic cancer. A study that included gemcitabine and nab-paclitaxel confirmed its acceptable safety.

Pamrevlumab, when used with gemcitabine and nab-paclitaxel, also demonstrated a consistent safety record in studies. Although it didn't always improve survival rates, it didn't cause additional safety issues.

SM-88, combined with methoxsalen, phenytoin, and sirolimus, was reported to be well-tolerated. Research found no serious or unexpected side effects specifically linked to SM-88.

These findings suggest that the treatments in this trial have generally been well-received by patients in previous studies. However, individual experiences may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for metastatic pancreatic cancer because they each offer unique approaches compared to traditional options like gemcitabine and nab-paclitaxel. Canakinumab and Spartalizumab work by targeting specific immune pathways, potentially enhancing the body's ability to fight cancer cells. Pamrevlumab stands out by targeting connective tissue growth factor, which plays a role in tumor progression and fibrosis, potentially limiting cancer spread. Meanwhile, SM-88 takes a novel approach by disrupting cancer cell metabolism, aiming to hinder cancer cell survival and growth. These innovative mechanisms provide new hope for improving outcomes in a condition with traditionally limited treatment options.

What evidence suggests that this trial's treatments could be effective for metastatic pancreatic cancer?

Research has shown promising results for several treatments in advanced pancreatic cancer. In this trial, participants may receive different treatment combinations. Canakinumab and spartalizumab, when combined with chemotherapy, have demonstrated better effects than using a single treatment. This combination remains safe and manageable for patients. Another treatment option in this trial is pamrevlumab, which, when added to standard chemotherapy, increased response rates but did not significantly improve overall survival compared to standard treatments alone. Meanwhile, SM-88, another treatment under study, has shown some effectiveness in shrinking tumors and extending life in advanced cases, with fewer side effects. These findings suggest potential benefits, but results vary, and more research is needed to confirm these effects. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive investigational drugs or standard of care therapy for metastatic pancreatic cancer

Up to 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term follow-up

Participants are assessed for overall survival and progression-free survival

Up to 24 months

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04581343

NCT04581343 | A Phase 1B Study of Canakinumab ... This is an open-label multi-center phase Ib study to confirm the recommended phase II/III dose of canakinumab and spartalizumab in combination with nab- ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11369625/

Blockade of IL1β and PD1 with Combination ... Combination of anti-IL1β with anti-PD1 checkpoint blockade results in improved therapeutic efficacy compared with either therapy alone (27). PD1 blockade in ...

3. aacrjournals.org aacrjournals.org/cancerres/article/82/22_Supplement/PR005/710433/Abstract-PR005-Primary-results-of-PanCAN-SR1-a

Abstract PR005: Primary results of PanCAN-SR1, a phase 1b ... PanCAN-SR1 established the Phase II dose of canakinumab and spartalizumab with chemotherapy in first line metastatic PDA, based upon favorable benefit-risk ...

4. targetedonc.com targetedonc.com/view/quad-combo-shows-safety-tolerability-in-pancreatic-cancer

Quad Combo Shows Safety, Tolerability in Pancreatic Cancer Canakinumab, spartalizumab, gemcitabine, and nab-paclitaxel in patients with metastatic pancreatic cancer was shown to be safe and tolerable in a phase 2 ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.e16287

Initial efficacy and biomarker analysis of a phase 1b study ... Conclusions: In this Phase Ib study, we established the Phase II/III dose of canakinumab and spartalizumab with chemotherapy in first line ...

6. mycancergenome.org mycancergenome.org/content/clinical_trials/NCT04581343/

Clinical Trial: NCT04581343 This study will confirm for this 4-drug combination the tolerable doses, the acceptable safety profile, and the dose to be used for a Phase II ...

7. cancer.gov cancer.gov/clinicaltrials/NCI-2020-09869

A Phase 1B Study of Canakinumab, Spartalizumab, Nab ... This study will confirm for this 4-drug combination the tolerable doses, the acceptable safety profile, and the dose to be used for a Phase II combination ...