Myeloid Immunotherapy for Pancreatic Cancer
(IGNITE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new immunotherapy treatment for individuals with advanced pancreatic cancer that cannot be surgically removed. The treatment uses two drugs, Mitazalimab and Odetiglucan, to assist the immune system in fighting cancer. The trial aims to determine if this treatment can maintain the condition of patients who have responded well to initial chemotherapy. Individuals with pancreatic cancer who have shown stable results or some improvement after 4-6 months of chemotherapy might be suitable candidates. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, you cannot have received any systemic treatment for pancreatic cancer within 14 days before starting the trial, and certain immunosuppressive agents are not allowed within 14 days of the first dose. 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?
Research has shown that Mitazalimab is safe and generally well-tolerated by patients with solid tumors, including advanced pancreatic cancer. One study found that patients could handle doses up to 1200 micrograms per kilogram without major problems and that Mitazalimab had promising effects against the cancer.
Odetiglucan has been tested and found safe for people with advanced pancreatic cancer, especially when combined with another treatment called CDX-1140. Patients who had previously responded to chemotherapy continued using Odetiglucan safely.
Both treatments have demonstrated encouraging safety profiles, with patients generally tolerating them well and experiencing manageable side effects.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Mitazalimab and Odetiglucan for pancreatic cancer because they offer a fresh approach compared to traditional chemotherapy methods. Mitazalimab is an antibody that targets and stimulates the immune system, potentially enhancing its ability to fight cancer cells more effectively. Odetiglucan, on the other hand, is a beta-glucan that can activate immune cells like macrophages, potentially boosting the body's natural defenses against tumors. Together, these treatments aim to harness the immune system to combat pancreatic cancer in a way that current treatments don't, offering hope for improved outcomes.
What evidence suggests that this trial's treatments could be effective for pancreatic cancer?
This trial studies Mitazalimab for its potential in treating pancreatic cancer. Previous studies have shown that patients who received Mitazalimab with chemotherapy lived for about 14.9 months on average, with over half experiencing tumor shrinkage. Odetiglucan, another treatment in this trial, remains in early testing. Researchers are investigating whether Odetiglucan can help prevent cancer growth after initial treatment. This is crucial because pancreatic cancer is difficult to treat, and extending control over it can significantly impact patient outcomes. Both treatments are being explored in this trial for their potential to offer better results than current options.26789
Are You a Good Fit for This Trial?
This trial is for adults over 18 with pancreatic adenocarcinoma that's advanced and can't be surgically removed. They should have completed 4-6 months of first-line chemo without the cancer getting worse, and must be feeling well enough to perform daily activities with minimal assistance.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Safety Run-in
Initial safety run-in phase evaluating dose-limiting toxicities over the first 21 days (Cycle 1)
Treatment
Full Phase II efficacy evaluation with maintenance CD40/Dectin-1 immunotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Mitazalimab
- Odetiglucan
Trial Overview
The study tests Odetiglucan and Mitazalimab as maintenance treatments in patients whose pancreatic cancer hasn't progressed after initial chemotherapy. It's a Phase II trial where all participants receive these immunotherapy drugs.
How Is the Trial Designed?
9
Treatment groups
Experimental Treatment
Active Control
Patients with locally advanced pancreatic adenocarcinoma who have achieved disease stability partial response (PR) or stable disease (SD) on 1L chemotherapy
Patients with metastatic adenocarcinoma achieving stable disease (SD) on 1L chemotherapy
Patients with metastatic pancreatic adenocarcinoma achieving a partial response (PR) on 1L chemotherapy
Observational Retrospective patient with metastatic pancreatic adenocarcinoma achieving a partial response (PR) on 1L chemotherapy
Observational Prospective Patients with locally advanced pancreatic adenocarcinoma who have achieved disease stability partial response (PR) or stable disease (SD) on 1L chemotherapy
Observational Prospective patient with metastatic pancreatic adenocarcinoma achieving a partial response (PR) on 1L chemotherapy
Observational Prospective Patients with metastatic adenocarcinoma achieving stable disease (SD) on 1L chemotherapy
Observational Retrospective Patients with metastatic adenocarcinoma achieving stable disease (SD) on 1L chemotherapy
Observational Retrospective Patients with locally advanced pancreatic adenocarcinoma who have achieved disease stability partial response (PR) or stable disease (SD) on 1L chemotherapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pennsylvania
Lead Sponsor
Lustgarten Foundation
Collaborator
Citations
CD40 agonist mitazalimab with mFOLFIRINOX in untreated ...
Median duration of response, progression-free survival, and overall survival was 12.6 months, 7.7 months, and 14.9 months, respectively. Multi- ...
CD40 agonist mitazalimab with mFOLFIRINOX in patients ...
This combination therapy has shown promising clinical efficacy compared to historical controls with a median OS of 14.9 months, median duration ...
3.
targetedonc.com
targetedonc.com/view/final-data-show-continued-responses-safety-by-mitazalimab-in-pancreatic-cancerFinal Data Show Continued Responses, Safety by ...
Mitazalimab, combined with chemotherapy, achieved a 54.4% objective response rate and 12.6-month median response duration in metastatic ...
Mitazalimab Plus Chemo Demonstrates Potential OS ...
The combination of mitazalimab and mFOLFIRINOX showed a median overall survival of 14.9 months in metastatic pancreatic cancer patients. The ...
A Maintenance Therapy Study of Odetiglucan With CDX ...
A Maintenance Therapy Study of Odetiglucan With CDX-1140 in Patients With Metastatic Pancreatic Ductal Adenocarcinoma. ClinicalTrials.gov ID NCT05484011.
Mitazalimab in combination with mFOLFIRINOX in patients ...
Mitazalimab has shown to be safe and well tolerated (at doses up to 1200 μg/kg), with signs of clinical activity in solid tumors in a Phase I ...
a single-arm, multicentre phase 1b/2 study
Mitazalimab with mFOLFIRINOX demonstrated manageable safety and encouraging activity, warranting continued development in a phase 3, randomised, controlled ...
NCT04888312 | Safety and Efficacy of Mitazalimab in ...
Phase 1b/2 study to assess the safety and efficacy of mitazalimab in combination with chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma.
265P CD40 agonist mitazalimab + mFOLFIRINOX in ...
The study met its primary endpoint with promising clinical efficacy vs. historical controls: median overall survival (mOS) 14.9 months, median duration of ...
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