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Comparing Length of Treatment with Immunotherapy in Patients with Advanced Solid Tumors

Trial Status: Active

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.

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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


University of Pittsburgh Cancer Institute (UPCI)
Status: ACTIVE
Contact: Antoinette J. Wozniak
Phone: 412-692-4724


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

Lead Organization
University of Pittsburgh Cancer Institute (UPCI)

Principal Investigator
Antoinette J. Wozniak

  • Primary ID HCC 19-135
  • Secondary IDs NCI-2020-02016
  • ID NCT04157985