Study of CBP501/Cisplatin/Nivolumab Combinations in Advanced Pancreatic Cancer (NCT04953962) | Clinical Trial Compass
CompletedPhase 2
Study of CBP501/Cisplatin/Nivolumab Combinations in Advanced Pancreatic Cancer
United States36 participantsStarted 2021-12-18
Plain-language summary
Multicenter, randomized, open-label, parallel group phase 2 study to assess the efficacy and tolerance of four combinations of CBP501, cisplatin, and nivolumab administered once every 21 days to patients with stage IV exocrine pancreatic cancer and WBC \< 10,000/mm3 at screening.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Signed informed consent obtained prior to initiation of any study-specific procedures and treatment;
✓. Patients with pathologically confirmed stage IV exocrine pancreatic cancer who have received at least two lines of systemic therapy for metastatic disease. Up to 10 of prior lines of systemic therapy (including prior cisplatin), chemoradiotherapy, radiotherapy or investigational agents the patient has received are allowed in order to be eligible, as long as all eligibility criteria are met, with the exception that a patient must not have received more than two prior lines incorporating anti-PD-1, anti-PD-L1, or anti-CTLA-4 immune checkpoint blockade.
✓. Male or female patients aged ≥ 18 years at time of informed consent;
✓. ECOG Performance Status (PS) 0-1;
✓. Life expectancy \> 3 months;
✓. Previous anticancer treatment must be discontinued at least 3 weeks prior to the initiation of study treatment (with the exception of 6 weeks for mitomycin C; 6 weeks for anti-androgen therapy if discontinued prior to treatment initiation, and 8 weeks for bicalutamide);
✓. Adequate bone marrow reserve, cardiac, liver, renal and metabolic function:
✓. Female patients of child-bearing potential must have a negative serum pregnancy test and use at least one form of contraception as approved by the investigator for 4 weeks prior to initiating study treatment and for 14 months after the last dose of study drug . For the purposes of this study, child-bearing potential is defined as "all female patients unless they are post-menopausal for at least 3 years or surgically sterile;
✕. Radiation therapy to \>30% of bone marrow prior to study entry;
✕. Prior chemotherapy with nitrosoureas, prior mitomycin C cumulative dose ≥ 25 mg/m2, prior bone marrow transplant, or prior intensive chemotherapy with stem cell support;
✕. Presence of any serious concomitant systemic disorders incompatible with the study in the opinion of the investigator (e.g., uncontrolled congestive heart failure, active infection, etc.);
✕. Any previous history of another malignancy (other than cured basal cell or squamous cell carcinoma of the skin or cured in-situ carcinoma) within 5 years of study entry;
✕. Presence of any significant central nervous system (CNS) or psychiatric disorder(s) that would hamper the patient's compliance;
✕. Evidence of peripheral neuropathy grade ≥ 2;
✕. Treatment with any other investigational agent or participation in another clinical trial within 28 days prior to study entry;
✕. Pregnant or breast-feeding patients or any patient with child-bearing potential not using adequate contraception;