Clinical trial NCT04157985: Evaluating Length of Treatment With PD-1/PD-L1 Inhibitor in Advanced Solid Tumors
Official title: Evaluating Length of Treatment With PD-1/PD-L1 Inhibitor in Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Advanced Solid Tumors
NSCLC
Bladder Cancer
HNSCC
Renal Cancer
Melanoma
Anal Cancer
Colorectal Cancer
Cholangiocarcinoma
Gastric Cancer
Hepatocellular Carcinoma
Merkel Cell Carcinoma
Cervical Cancer
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2019-11-08
Enrollment: 578
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Within the UPMC system, approximately 2,300 patients received PD-1/PD-L1 therapy for a variety of advanced solid tumors within the past year. It is anticipated that this number will increase as the clinical indications for treatment with these agents also increase. The investigators conducted a survey of 60 Medical Oncologists within the UPMC system regarding their interest in a trial that will attempt to address the question of optimal length of PD-1/PD-L1 treatment. Fifty-two (86.7%) physicians indicated that they would participate in a clinical trial that had a primary goal of determining whether it was feasible to stop immunotherapy after 1 year of treatment.

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.

Primary outcomes:
measure: Time to next treatment
timeFrame: Up to 36 months
measure: Progression-free Survival (PFS) (at between 2-3.9 months)
timeFrame: Between 2 months and 3.9 months
measure: Progression-free Survival (PFS) (at between 4-7.9 months)
timeFrame: Between 4 months and 7.9 months
measure: Progression-free Survival (PFS)
timeFrame: Up to 36 months
Secondary outcomes:
measure: Incidence of irAEs (Immune-Related Adverse Events)
timeFrame: Up to 36 months
measure: Overall Survival (OS)
timeFrame: Up to 36 months
measure: Best Objective Response (BOR)
timeFrame: Up to 36 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
Study officials:
affiliation: UPMC Hillman Cancer Center
name: Jason Luke, MD
role: PRINCIPAL_INVESTIGATOR
References: