Evaluating Length of Treatment With PD-1/PD-L1 Inhibitor in Advanced Solid Tumors

Official Summary

Based on the overwhelming positive response to this survey and the large number of patients being treated with PD-1/PD-L1 therapy in the UPMC system, the investigators are proposing a trial that will randomize patients who have disease stability to stop treatment at 1 year or continue treatment until disease progression. The investigators anticipate that the results of this study will answer questions regarding the optimal duration of treatment. therapy.

Eligibility Requirements

• Minimum Age: 18 Years

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 161 participants

Study Arms

• Continue Treatment with PD-1/PD-L1 inhibitor (ACTIVE_COMPARATOR)
  Continued standard of care treatment with PD-1/PD-L1 -1 checkpoint inhibitor after 12 months of checkpoint inhibitor treatment.
• Discontinue Treatment with PD-1/PD-L1-1 inhibitor (EXPERIMENTAL)
  Discontinued standard of care treatment with PD-1/PD-L1 -1 checkpoint inhibitor after 12 months of checkpoint inhibitor treatment.

Interventions

• DRUG: Continue PD-1/PD-L1 Inhibitors treatment — Continued treatment with PD-1/PD-L1-1 inhibitor
• OTHER: Discontinue PD-1/PD-L1-1 inhibitor — Discontinued treatment with PD-1/PD-L1-1 inhibitor

Primary Outcomes

• Time to next treatment (Up to 36 months)
• Progression-free Survival (PFS) (at between 2-3.9 months) (Between 2 months and 3.9 months)
• Progression-free Survival (PFS) (at between 4-7.9 months) (Between 4 months and 7.9 months)
• Progression-free Survival (PFS) (Up to 36 months)

Secondary Outcomes

• Incidence of irAEs (Immune-Related Adverse Events) (Up to 36 months)
• Overall Survival (OS) (Up to 36 months)
• Best Objective Response (BOR) (Up to 36 months)

Eligibility Criteria

Inclusion Criteria:

* All patients must have an advanced solid tumor malignancy (specifically NSCLC, bladder, HNSCC, renal, melanoma, cervical, Merkel cell, MMR/MSI \[colon, rectal, cholangio, esophageal, ovarian, uterine\], anal, gastric and 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, ipilumumab, 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 ± 6 weeks versus continued treatment beyond 1 year.
* Patients can have measurable or non-measurable disease per RECIST v1.1.
* 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.

Trial Locations

• UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States

Study Officials

• Dan Zandberg, MD — PRINCIPAL_INVESTIGATOR
  UPMC Hillman Cancer Center

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