Combination Therapy for Pancreatic Cancer
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Gulam Manji
Must not be taking: Immunosuppressants, Investigational agents
Disqualifiers: Autoimmune disease, CNS metastases, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial tests a combination of standard chemotherapy, an immune-boosting drug, and a new drug to treat aggressive pancreatic cancer. The goal is to see if this mix can shrink tumors and help patients live longer. The treatment aims to kill cancer cells directly and enhance the body's immune response against the cancer. Gemcitabine is currently the standard treatment for advanced pancreatic cancer.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot be on other investigational agents or certain immunosuppressive medications. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug combination therapy for pancreatic cancer?
Research shows that combining nab-paclitaxel (Abraxane) with gemcitabine improves survival in patients with advanced pancreatic cancer compared to using gemcitabine alone. This combination has demonstrated superior activity and efficacy in clinical trials.
12345What safety data exists for the combination therapy involving Cemiplimab, Gemcitabine, Motixafortide, and Nab paclitaxel?
Studies have shown that the combination of nab-paclitaxel and gemcitabine has an acceptable safety profile in patients with advanced pancreatic cancer and other solid tumors. This suggests that these drugs are generally safe for use in humans, although specific safety data for the exact combination therapy you mentioned may not be available.
678910How is the combination therapy of Cemiplimab, Gemcitabine, and Nab paclitaxel unique for treating pancreatic cancer?
This combination therapy is unique because it includes Cemiplimab, an immunotherapy drug that helps the immune system fight cancer, alongside Gemcitabine and Nab paclitaxel, which have shown improved survival rates in pancreatic cancer patients compared to Gemcitabine alone.
1351112Eligibility Criteria
Adults over 18 with stage IV pancreatic adenocarcinoma, not endocrine or acinar types, who haven't had recent major surgery or cancer treatments. They must have a good performance status and organ function, no severe allergies to study drugs, and agree to use birth control if applicable.Inclusion Criteria
Ability to comply with study protocol according to investigator's judgement
My cancer is not endocrine or acinar pancreatic carcinoma.
My liver tests are normal or slightly elevated due to a blockage that can be treated.
+27 more
Exclusion Criteria
I have skin conditions like eczema or psoriasis but only on my skin.
I have had surgery for pancreatic cancer.
History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
+33 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Priming
Participants receive motixafortide daily for 5 days to prime the immune system
1 week
Treatment
Participants receive motixafortide twice a week, cemiplimab once every three weeks, and standard chemotherapy (gemcitabine and nab-paclitaxel)
16 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Up to 5 years
Participant Groups
The trial tests a combination of chemotherapy (gemcitabine and nab-paclitaxel), immunotherapy (cemiplimab), and a chemokine inhibitor (motixafortide) for effectiveness in shrinking tumors, extending life, and safety in metastatic pancreatic cancer patients.
1Treatment groups
Experimental Treatment
Group I: Motixafortide, Cemiplimab, Gemcitabine, Nab-PaclitaxelExperimental Treatment4 Interventions
Participants will receive standard FDA-approved doses of gemcitabine and nab-paclitaxel for pancreas cancer and cemiplimab at the dose that is approved for participants with skin cancer. Participants will also receive motixafortide at a dose that has been deemed safe in previous studies when used in combination with immunotherapy and chemotherapy. If the combination study treatment causes a serious side effect in participants, the study treatment will be modified.
Cemiplimab is already approved in European Union, United States, Canada, Brazil for the following indications:
🇪🇺 Approved in European Union as Libtayo for:
- Cutaneous squamous cell carcinoma (CSCC)
- Non-small cell lung cancer (NSCLC)
🇺🇸 Approved in United States as Libtayo for:
- Cutaneous squamous cell carcinoma (CSCC)
- Basal cell carcinoma (BCC)
- Non-small cell lung cancer (NSCLC)
🇨🇦 Approved in Canada as Libtayo for:
- Cutaneous squamous cell carcinoma (CSCC)
- Non-small cell lung cancer (NSCLC)
🇧🇷 Approved in Brazil as Libtayo for:
- Cutaneous squamous cell carcinoma (CSCC)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Columbia University Irving Medical CenterNew York, NY
Brown UniversityProvidence, RI
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Who Is Running the Clinical Trial?
Gulam ManjiLead Sponsor
Regeneron PharmaceuticalsIndustry Sponsor
BioLine RxCollaborator
References
The Association of Drug-Funding Reimbursement With Survival Outcomes and Use of New Systemic Therapies Among Patients With Advanced Pancreatic Cancer. [2023]Gemcitabine-nab-paclitaxel (GEMNAB) and fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) both improve survival of patients with advanced pancreatic cancer when compared with single-agent gemcitabine in clinical trials.
A phase I trial of nab-paclitaxel, gemcitabine, and capecitabine for metastatic pancreatic cancer. [2022]Substantial antitumor activity has previously been demonstrated with the addition of nab-paclitaxel (Abraxane [Celgene, Summit, NJ]), an albumin-bound formulation of paclitaxel, to gemcitabine in patients with advanced pancreatic cancer. Given preclinical evidence of synergy when a fluoropyrimidine is added to gemcitabine plus a taxane in a sequence-specific schedule, we conducted a phase I study to evaluate the combination of nab-paclitaxel, gemcitabine, and capecitabine administered biweekly in patients with metastatic pancreatic adenocarcinoma.
NAB-paclitaxel and gemcitabine in metastatic pancreatic ductal adenocarcinoma (PDAC): from clinical trials to clinical practice. [2023]Pancreatic adenocarcinoma is an aggressive disease with poor prognosis. In a randomized phase III trial, combination of Nab-paclitaxel (Nab-P) plus gemcitabine showed superior activity and efficacy in first-line treatment compared with gemcitabine alone.
Gemcitabine in the treatment of advanced pancreatic cancer: a comparative analysis of randomized trials. [2022]In view of the data available from randomized trials, gemcitabine has been established as a new standard for the treatment of pancreatic cancer. It was shown to improve clinical benefit response, time to progression, and survival when compared with agents such as 5-fluorouracil or metalloproteinase inhibitors. In one trial, the combination of cisplatin and gemcitabine significantly improved tumor response and time to progression as compared with gemcitabine alone, while a significant impact on survival yet needs to be shown. No significant, clinically meaningful survival benefit was observed when gemcitabine was combined with bolus or infusional 5-fluorouracil, capecitabine, metalloproteinase inhibitors, or the FTI tipifarnib. Numerous ongoing randomized trials are presently investigating gemcitabine-based combination regimens involving such agents as cisplatin, oxaliplatin, irinotecan, docetaxel, 5-fluorouracil, capecitabine, or pemetrexed.
nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine in Patients with Metastatic Pancreatic Adenocarcinoma: Canadian Subgroup Analysis of the Phase 3 MPACT Trial. [2023]The phase III MPACT trial in patients with metastatic pancreatic cancer (MPC) demonstrated superior efficacy of nab-paclitaxel (nab-P) plus gemcitabine (Gem) compared with Gem monotherapy, including the primary endpoint of overall survival (OS; median 8.7 vs. 6.6 months; hazard ratio [HR] 0.72; P
A Phase Ib/II Study of the JAK1 Inhibitor, Itacitinib, plus nab-Paclitaxel and Gemcitabine in Advanced Solid Tumors. [2022]Label="LESSONS LEARNED">Itacitinib in combination with nab-paclitaxel plus gemcitabine demonstrated an acceptable safety profile with clinical activity in patients with advanced solid tumors including pancreatic cancer.The results support future studies of itacitinib as a component of combination regimens with other immunologic and targeted small molecule anticancer agents.
Adjuvant nab-Paclitaxel + Gemcitabine in Resected Pancreatic Ductal Adenocarcinoma: Results From a Randomized, Open-Label, Phase III Trial. [2023]Label="PURPOSE">This randomized, open-label trial compared the efficacy and safety of adjuvant nab-paclitaxel + gemcitabine with those of gemcitabine for resected pancreatic ductal adenocarcinoma (ClinicalTrials.gov identifier: NCT01964430).
CD40 agonistic monoclonal antibody APX005M (sotigalimab) and chemotherapy, with or without nivolumab, for the treatment of metastatic pancreatic adenocarcinoma: an open-label, multicentre, phase 1b study. [2022]Standard chemotherapy remains inadequate in metastatic pancreatic adenocarcinoma. Combining an agonistic CD40 monoclonal antibody with chemotherapy induces T-cell-dependent tumour regression in mice and improves survival. In this study, we aimed to evaluate the safety of combining APX005M (sotigalimab) with gemcitabine plus nab-paclitaxel, with and without nivolumab, in patients with pancreatic adenocarcinoma to establish the recommended phase 2 dose.
Open-label, Phase I Study of Nivolumab Combined with nab-Paclitaxel Plus Gemcitabine in Advanced Pancreatic Cancer. [2022]Label="PURPOSE">Assess safety and efficacy of nivolumab plus nab-paclitaxel and gemcitabine in patients with locally advanced/metastatic pancreatic cancer in a two-part, open-label, phase I trial.
Clinical efficacy of nab-paclitaxel in patients with metastatic pancreatic cancer. [2022]Label="PURPOSE" NlmCategory="OBJECTIVE">Pancreatic carcinoma is the neoplasia with the major mortality, and main standard treatments in this cancer increase survival but do not lead to complete recovery of the patient. The aim of this study was to evaluate the efficacy of Abraxane® (nab-paclitaxel) in Italian patients with metastatic pancreatic cancer (MPC).
First-line nab-paclitaxel and gemcitabine in patients with metastatic pancreatic cancer from routine clinical practice. [2022]The combination of nab-paclitaxel and gemcitabine is a new effective first-line chemotherapy for patients with metastatic pancreatic cancer. This was demonstrated in the phase III MPACT trial.
Nab-paclitaxel and gemcitabine for the treatment of patients with metastatic pancreatic cancer. [2022]Adenocarcinoma of the pancreas or pancreatic cancer as we will refer to it here, is a cancer of poor prognosis with a high mortality, particularly in the advanced or metastatic setting. Until 2011 and the Phase III results of FOLFIRINOX, standard treatment options were limited to gemcitabine. Combination therapy had shown either a lack of or very limited improvement versus monotherapy with gemcitabine. With the positive results of the MPACT study in 2013 showing improved survival with nab-paclitaxel plus gemcitabine combination therapy, there are now more options for oncologists to treat patients with advanced pancreatic cancer. This paper will highlight the Phase I/II and Phase III trials of nab-paclitaxel plus gemcitabine along with discussing their biology and further possible development in treating patients with pancreatic cancer.