Trial purpose
Cancer treatment
Tumor type
Upper gastrointestinal tract
Age
18+
Trial acronym
Met Pancreatic
Clinical summary
Summary
This is an open-label, multi-center, randomized, Phase 3 study designed to compare the efficacy and safety of AM0010 in combination with FOLFOX versus FOLFOX alone in patients with metastatic adenocarcinoma of the pancreas who have progressed on one prior gemcitabine containing regimen.
Conditions
This trial is treating people with Pancreatic Cancer
Eligibility
Inclusion
- The presence of metastatic pancreatic adenocarcinoma
- Measurable disease per RECIST v.1.1
- Participant must have documented tumor progression during or following a gemcitabine containing regimen to treat metastatic disease as established by CT or MRI scan
- Eastern Cooperative Oncology Group Performance Status of 0 - 1
- Participant must have completed prior chemotherapy at least 2 weeks (washout period) prior to randomization and recovered from toxicity to Grade 1 or baseline
- Participants must not have received previous radiation therapy or investigational therapy for the treatment of advanced metastatic disease.
- Participants having received cytotoxic doses of gemcitabine or any other chemotherapy in the adjuvant setting are not eligible for this study
- No peripheral neuropathy
- No known history of dihydropyrimidine dehydrogenase deficiency
Exclusion
- Diagnosis of pancreatic islet neoplasm, acinar cell carcinoma, non- adenocarcinoma (i.e., lymphoma, sarcoma), adenocarcinoma originating from the biliary tree, or cystadenocarcinoma
- Participant on Coumadin and not willing to change to LMWH or oral Factor II or Xa inhibitor with half-life of less than 24 hours.
- Participant has received prior treatment with pegilodecakin or fluoropyrimidine/platinum containing regimen
- Participants who were intolerant of a gemcitabine containing regimen.
- History of positivity for human immunodeficiency virus
- Chronic active or active viral hepatitis A, B, or C infection
- Clinically significant bleeding within two weeks prior to randomization (e.g., gastrointestinal (GI) bleeding, intracranial hemorrhage)
- Pregnant or lactating women
- Participants with a history of immune-mediated neurological disorders such as multiple sclerosis, Guillain-Barré or inflammatory CNS/PNS disorders
- Clinically significant ascites defined as requiring ≥ 1 paracentesis every 2- weeks
- Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e., larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy),within 28 days prior to randomization or anticipated surgery during the study period
- Prior history of receiving immune modulators including, but not limited to, anti-CTLA4, anti-PD1, anti-PD-L1
Inclusion
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
- You are currently being treated on a clinical trial.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
ARMO Biosciences
Scientific Title
Randomized Study of AM0010 in Combination With FOLFOX Compared to FOLFOX Alone as Second-line Tx in Pts With Meta Pancreatic Cancer That Has Progressed During or Following a First-Line Gemcitabine Containing Regimen
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