This phase III trial compares 1 year immunotherapy treatment versus continuous immunotherapy treatment beyond 1 year in patients with solid tumors that have spread to other places in the body (advanced). Immunotherapy such as pembrolizumab, nivolumab, atezolizumab, durvalumab, and avelumab are drugs given through a vein to the entire body to activate the immune system. Comparing the treatment lengths may help doctors determine the ideal length of time for treatment with immunotherapy in patients with solid tumors.
Additional locations may be listed on ClinicalTrials.gov for NCT04157985.
Locations matching your search criteria
United States
Pennsylvania
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)Status: Active
Contact: Jason John Luke
Phone: 412-623-4511
PRIMARY OBJECTIVE:
I. To assess the time to next treatment of patients with advanced solid tumors who are randomized to receive PD-1/PD-L1 inhibitors for 1 year versus continuing beyond 1 year.
SECONDARY OBJECTIVES:
I. To assess the incidence of immune-related adverse events (irAEs) that occur after 1 year of treatment for all patients.
II. To assess the overall survival of the patients randomized to 1 year of treatment versus those treated beyond 1 year.
III. To determine the efficacy of PD-1/PD-L1 agents in patients who restart these agents for disease progression.
EXPLORATORY OBJECTIVE:
I. To collect blood at the time of randomization and at disease progression for future translational studies.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive standard of care pembrolizumab, nivolumab, atezolizumab, durvalumab, or avelumab for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) scan, magnetic resonance imaging (MRI) or positron emission tomography (PET) scan and blood sample collection throughout the study.
ARM II: Patients receive standard of care pembrolizumab, nivolumab, atezolizumab, durvalumab, or avelumab in the absence of disease progression or unacceptable toxicity. Treatment with pembrolizumab stops at 2 years or 35 cycles. Patients undergo CT scan, MRI or PET scan and blood sample collection throughout the study.
After completion of study treatment, patients are followed up every 3 months until study close.
Lead OrganizationUniversity of Pittsburgh Cancer Institute (UPCI)
Principal InvestigatorJason John Luke
