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Evaluation of the Length of Treatment With PD-1/PD-L1 Inhibitors in Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04157985
Recruitment Status : Recruiting
First Posted : November 8, 2019
Last Update Posted : December 4, 2019
Information provided by (Responsible Party):
Antoinette J Wozniak, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE November 6, 2019
First Posted Date  ICMJE November 8, 2019
Last Update Posted Date December 4, 2019
Actual Study Start Date  ICMJE November 15, 2019
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2019)
Time to next treatment [ Time Frame: Up to 36 months ]
In patients who have already been treated with a PD-1 or PD-L1 inhibitor for one year, the difference in progression-free survival (time to next treatment, progression or death, whichever occurs first) between patients who stop treatment and patients who continue treatment.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04157985 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2019)
  • Incidence of irAEs (Immune-Related Adverse Events) [ Time Frame: Up to 36 months ]
    Proportion of participants in a disease stratum and treatment arm who experience at least one AE of any grade (per Common Terminology Criteria for Adverse Events (CTCAE v5.0)), at least possibly related to treatment in the categories of colitis, hepatitis, pnemonitis, hypophysitis or hypopituitarism, hypothyroidism, fatigue, diarrhea, rash, arthritis, arthralgia, back pain, musculoskeletal pain or myalgia, or any other category that is felt to be related to treatment.
  • Overall Survival (OS) [ Time Frame: Up to 36 months ]
    The length of time from the start of treatment that patients are still alive.
  • Best Objective Response (BOR) [ Time Frame: Up to 36 months ]
    Proportions of participants who restart for disease progression in each disease stratum, who experience a best objective response (progressive disease, stable disease, partial response, complete response) per RECIST v1.1 (Response Evaluation Criteria in Solid Tumors);Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to <10 mm;Partial Response (PR): ≥ 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters;Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, (reference smallest sum diameters);Progressive Disease (PD): ≥ 20% increase in the sum of diameters of target lesions (reference smallest sum diameters); the sum must also demonstrate an absolute increase of at least 5 mm; (appearance ≥ 1 new lesions is considered progression).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Evaluation of the Length of Treatment With PD-1/PD-L1 Inhibitors in Patients With Advanced Solid Tumors
Official Title  ICMJE A Randomized Non-inferiority Trial Evaluating the Length of Treatment With PD-1/PD-L1 Inhibitors in Patients With Advanced Solid Tumors
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Solid Tumors
  • Bladder Cancer
  • Renal Cancer
  • Melanoma
  • Anal Cancer
  • Colorectal Cancer
  • Cholangiocarcinoma
  • Gastric Cancer
  • Hepatocellular Carcinoma
Intervention  ICMJE
  • Drug: Continue PD-1/PD-L1 Inhibitors treatment
    Continued treatment with PD-1/PD-L1-1 inhibitor
    Other Names:
    • Keytruda (pembrolizumab)
    • Optiva (nivolumab)
    • Tecentriq (atezolizumab)
    • Yervoy (ipilimumab)
  • Other: Discontinue PD-1/PD-L1-1 inhibitor
    Discontinued treatment with PD-1/PD-L1-1 inhibitor
Study Arms  ICMJE
  • Active Comparator: Continue Treatment with PD-1/PD-L1 inhibitor
    Continued standard of care treatment with PD-1/PD-L1 -1 checkpoint inhibitor after 12 months of checkpoint inhibitor treatment.
    Intervention: Drug: Continue PD-1/PD-L1 Inhibitors treatment
  • Experimental: Discontinue Treatment with PD-1/PD-L1-1 inhibitor
    Discontinued standard of care treatment with PD-1/PD-L1 -1 checkpoint inhibitor after 12 months of checkpoint inhibitor treatment.
    Intervention: Other: Discontinue PD-1/PD-L1-1 inhibitor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 6, 2019)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2021
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All patients must have an advanced solid tumor malignancy 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 ± 4 weeks versus continued treatment beyond 1 year.
  • Patients can have measurable or non-measurable disease per 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Daniel Goldstein, BSN 412-864-7820
Contact: Carrie Muniz, BSN 412-623-6121
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT04157985
Other Study ID Numbers  ICMJE 19-135
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Antoinette J Wozniak, University of Pittsburgh
Study Sponsor  ICMJE Antoinette J Wozniak
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Antoinette J Wozniak, MD, FACP UPMC Hillman Cancer Center
PRS Account University of Pittsburgh
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP