AGEN1423 + Balstilimab With/Without Chemo for Pancreatic Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Bruno Bockorny
Must not be taking: Immunosuppressants, Steroids
Disqualifiers: Other pancreatic tumors, Active infection, Autoimmune disease, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial is testing new drugs AGEN1423 and Balstilimab, alone or with chemotherapy, for advanced pancreatic cancer patients who didn't respond to previous treatments. The treatment aims to boost the immune system to fight cancer.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot be on systemic steroid therapy or immunosuppressive therapy within 7 days before starting the trial. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug combination AGEN1423, Balstilimab, and chemotherapy for pancreatic cancer?
The combination of gemcitabine and albumin-bound paclitaxel (a form of chemotherapy) is a standard treatment for metastatic pancreatic cancer, showing a significant survival benefit compared to gemcitabine alone. This suggests that combining chemotherapy with other drugs like AGEN1423 and Balstilimab could potentially enhance treatment effectiveness.
12345Is the combination of AGEN1423, Balstilimab, and chemotherapy safe for humans?
The safety of immune checkpoint inhibitors (like Balstilimab) has been studied, and they can cause immune-related side effects, including issues with the pancreas. Gemcitabine, a chemotherapy drug, has been used in various studies and is generally considered safe, but it can have side effects like any chemotherapy. There is no specific safety data available for AGEN1423 in the provided research.
46789How is the drug AGEN1423 + Balstilimab with/without chemo unique for pancreatic cancer?
AGEN1423 + Balstilimab is unique because it combines immunotherapy agents, which aim to boost the body's immune response against cancer, with or without chemotherapy, offering a novel approach compared to traditional chemotherapy regimens like FOLFIRINOX or gemcitabine-based treatments that are typically used for pancreatic cancer.
35101112Eligibility Criteria
This trial is for adults with advanced pancreatic ductal adenocarcinoma that's worsened after treatment. They must understand the study, sign consent, have good organ function, use contraception, and not be eligible for curative therapy. Exclusions include other active cancers or treatments, certain medical conditions like heart disease or lung issues, recent vaccines, pregnancy/breastfeeding intentions during the trial period.Inclusion Criteria
My side effects from the last chemotherapy are mostly gone, except for hair loss and nerve issues.
You are expected to live for at least 3 more months.
Subjects must use effective contraception
+6 more
Exclusion Criteria
I have not received a live vaccine in the last 30 days.
I have an immune system disorder or have taken steroids in the past week.
I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.
+22 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive AGEN1423 plus Botensilimab for 4 cycles (8 weeks) followed by Botensilimab alone or with chemotherapy for up to 2 years
2 years
Every 2 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
1 year
Participant Groups
The study tests AGEN1423 and Balstilimab combined with or without chemotherapy drugs gemcitabine and nab-paclitaxel in treating advanced pancreatic cancer. Participants will receive this treatment over two years and then be monitored for an additional year to assess safety and effectiveness.
2Treatment groups
Experimental Treatment
Group I: COHORT 2: AGEN1423 Plus Botensilimab and ChemotherapyExperimental Treatment4 Interventions
Treatment is AGEN1423 plus Botensilimab in combination with gemcitabine and nab-paclitaxel for 2 cycles (8 weeks) followed by Botensilimab in combination with gemcitabine and nab-paclitaxel for up to 2 years. AGEN1423 will be administered in a total of 4 doses. Botensilimab will be administered once every 2 weeks.
Group II: COHORT 1: AGEN1423 Plus BotensilimabExperimental Treatment2 Interventions
Treatment is AGEN1423 plus Botensilimab for 4 cycles (8 weeks) followed by Botensilimab alone for up to 2 years. AGEN1423 will be administered in a total of 4 doses. Botensilimab will be administered every 2 weeks.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Beth Israel Deaconess Medical CenterBoston, MA
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Who Is Running the Clinical Trial?
Bruno BockornyLead Sponsor
Bruno Bockorny, MDLead Sponsor
Dana-Farber Cancer InstituteCollaborator
Agenus Inc.Industry Sponsor
References
Clinical Activity and Safety of Cediranib and Olaparib Combination in Patients with Metastatic Pancreatic Ductal Adenocarcinoma without BRCA Mutation. [2022]Cediranib and olaparib combination did not result in clinically meaningful activity in patients with metastatic pancreatic ductal adenocarcinoma without known BRCA mutation.
Phase 1 trials in pancreatic cancer. [2022]Despite many clinical trials over the last two decades since the approval of gemcitabine, the survival of patients with pancreatic cancer has improved by a few only months. This disappointing reality underlines an urgent need to develop more effective drugs or better combinations. A variety of phase I trials were presented at the annual meeting of ASCO 2014 focusing on locally advanced and metastatic pancreatic cancer. We summarize four abstracts (abstracts #4116, #4123, #4026, #4138).
Clinical Management: Metastatic Disease. [2018]Most patients with pancreatic cancer either present with or eventually develop metastatic disease during the course of their illness. For such individuals, systemic therapy, namely, cytotoxic therapy, represents the mainstay of treatment and is administered with noncurative intent. Of the various chemotherapy options now available for treating metastatic pancreatic cancer, 2 combination regimens, FOLFIRINOX (infusional 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin) and the doublet of gemcitabine and albumin-bound paclitaxel, have emerged as frontline standards of care, based on phase III studies demonstrating a significant survival benefit compared with single-agent gemcitabine. More patients are also now able to be sequenced through 2 or more lines of treatment, with newer regimens such as nanoliposomal irinotecan plus infusional 5-fluorouracil and leucovorin receiving US Food and Drug Administration approval specifically for use in this second-line setting. Selection of therapies remains primarily guided by clinical considerations, particularly performance status, as well as age, comorbid medical conditions, and organ and bone marrow function. In contrast, molecular predictors of efficacy and toxicity have not yet been validated in this disease context. Areas of novel therapeutic development include targeting the stromal microenvironment, exploring combinations of immunotherapeutic agents, and identifying molecular subsets of metastatic pancreatic cancer that may uniquely susceptible to specific strategies, such as hampering DNA damage repair.
A phase 3 randomized, double-blind, placebo-controlled trial of ganitumab or placebo in combination with gemcitabine as first-line therapy for metastatic adenocarcinoma of the pancreas: the GAMMA trial. [2022]This double-blind, phase 3 study assessed the efficacy and safety of ganitumab combined with gemcitabine as first-line treatment of metastatic pancreatic cancer.
A multicentre randomised phase II trial of gemcitabine alone vs gemcitabine and S-1 combination therapy in advanced pancreatic cancer: GEMSAP study. [2022]This randomised phase II trial compared gemcitabine alone vs gemcitabine and S-1 combination therapy in advanced pancreatic cancer.
Randomised phase II trial of irinotecan plus S-1 in patients with gemcitabine-refractory pancreatic cancer. [2022]We aimed to compare the efficacy and safety of irinotecan/S-1 (IRIS) therapy with S-1 monotherapy in patients with gemcitabine-refractory pancreatic cancer.
Pancreatic Adverse Events Associated With Immune Checkpoint Inhibitors: A Large-Scale Pharmacovigilance Analysis. [2022]Backgrounds: Immune checkpoint inhibitors (ICIs) are considered cornerstones of oncology treatment with durable anti-tumor efficacy, but the increasing use of ICIs is associated with the risk of developing immune-related adverse events (irAEs). Although ICI-associated pancreatic adverse events (AEs) have been reported in patients treated with ICIs, the clinical features and spectrum of pancreatic AEs are still not well-defined. Therefore, this study aimed to identify the association between pancreatic AEs and ICIs treatments and to characterize the main features of ICI-related pancreatic injury (ICIPI) based on the Food and Drug Administration Adverse Event Reporting System (FAERS) database.
Lenalidomide in combination with gemcitabine as first-line treatment for patients with metastatic carcinoma of the pancreas: a Sarah Cannon Research Institute phase II trial. [2022]To evaluate the 6-mo overall survival, safety and tolerability of lenalidomide in combination with standard gemcitabine as first-line treatment for patients with metastatic pancreatic cancer.
Safety and activity of the TGFβ receptor I kinase inhibitor galunisertib plus the anti-PD-L1 antibody durvalumab in metastatic pancreatic cancer. [2021]We assessed the safety, efficacy, and pharmacokinetics of the transforming growth factor beta (TGFβ) receptor inhibitor galunisertib co-administered with the anti-programmed death-ligand 1 (PD-L1) antibody durvalumab in recurrent/refractory metastatic pancreatic cancer previously treated with ≤2 systemic regimens.
Best practices for the treatment of metastatic pancreatic adenocarcinoma: the therapeutic landscape in 2017. [2018]The vast majority of patients diagnosed with pancreatic adenocarcinoma have inoperable, most commonly metastatic, disease at the time of initial presentation, at which point systemic therapy becomes the mainstay of treatment. Although survival rates remain very poor in this clinical setting, patients currently have a greater number of therapeutic options available to them than ever before, and consequently individuals are more frequently able to be sequenced through multiple lines of treatment. In this review, we will provide an overview of the current treatment landscape for metastatic pancreatic cancer in 2017, focusing on best practices and the various factors that should be considered in selecting the most appropriate regimen for a given individual. Options for front-line therapy include both infusional 5-fluorouracil, leucovorin, irinotecan, oxaliplatin (FOLFIRINOX) and the combination of gemcitabine plus nab-paclitaxel; however, how to choose between these two regimens can sometimes pose a challenging problem, and some patients may not be suitable candidates for either. For patients who are robust enough to receive second-line therapy (and beyond), the selection of treatment depends in part on their prior treatment exposure; newer drugs such as nanoliposomal irinotecan (nal-IRI) (in combination with infusional 5-fluorouracil and leucovorin) are now approved by the United States Food and Drug Administration (FDA) specifically for use following disease progression on first-line gemcitabine-based therapy. Despite these welcome advances in standard of care treatment, patients should still be encouraged to participate in clinical trials whenever possible.
First line treatment for metastatic pancreatic adenocarcinoma: looking for the step forward. [2022]Pancreatic cancer is a lethal disease and its prognosis remains dismal. The modest results of existing available treatments in the first line setting reveal the need of new therapeutic strategies. In this year's American Society of Clinical Oncology (ASCO) Annual Meeting four remarkable studies were presented regarding this vulnerable group of patients. The efficacy and toxicity profile of gemcitabine plus erlotinib plus capecitabine (Abstract #4122), refametinib plus gemcitabine (Abstract #4025), gemcitabine plus docetaxel plus capecitabine plus cisplatin (Abstract #4135) were examined and the predictive value of a biomarker panel testing response to gemcitabine with or without the addition of erlotinib (Abstract #4133) was also presented.
Treatment outcome for systemic chemotherapy for recurrent pancreatic cancer after postoperative adjuvant chemotherapy. [2022]A global consensus on how to treat recurrent pancreatic cancer after adjuvant chemotherapy with gemcitabine (ADJ-GEM) does not exist.