Comparing Length of Treatment with Immunotherapy in Patients with Advanced Solid Tumors
- All patients must have an advanced solid tumor malignancy (specifically non-small cell lung cancer [NSCLC], bladder, head and neck squamous cell cancer [HNSCC], renal, melanoma, mismatch repair [MMR]/microsatellite instability [MSI] [colon, rectal, cholangio, esophageal, ovarian, uterine], anal, gastric and gastroesophageal [GE] junction, hepatocellular, triple negative breast cancer) that is being treated with a PD-1/PD-L1 inhibitor including pembrolizumab, nivolumab, atezolizumab, durvalumab, or avelumab according to standard of care treatment
- Patients who initially started treatment with another agent in combination with the PD-1/PD-L1 inhibitor, i.e. chemotherapy, ipilimumab, are eligible
- Patients must have at least stable disease as evidenced by scans performed within 6 weeks of randomization
- Signed Informed consent allowing randomization to stopping immunotherapy at 1 year +/- 4 weeks versus continued treatment beyond 1 year
- Patients can have measurable or non-measurable disease per Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST)
- Patients cannot be enrolled in a clinical trial
- Patients with documented progressive disease prior to randomization
- Patients with an immune-related toxicity preventing the continuation of treatment beyond 1 year at the treating physician’s discretion. Patients whose treatment is being held at 1 year will not be eligible to participate
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.
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.
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.
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.
After completion of study treatment, patients are followed up every 3 months until study close.
Trial Phase Phase III
Trial Type Treatment
University of Pittsburgh Cancer Institute (UPCI)
Antoinette J. Wozniak
- Primary ID HCC 19-135
- Secondary IDs NCI-2020-02016
- Clinicaltrials.gov ID NCT04157985