Skip to main content
OpenTrials
Completed

NCT Number: NCT04157985

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Advanced Solid Tumors Adenocarcinoma Anal Cancer Anus Diseases Anus Neoplasms Bladder Cancer Carcinoma Carcinoma, Hepatocellular Carcinoma, Merkel Cell Carcinoma, Neuroendocrine Carcinoma, Squamous Cell Cervical Cancer Cholangiocarcinoma Colonic Diseases Colorectal Cancer Colorectal Neoplasms DNA Virus Infections Digestive System Diseases Digestive System Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female HNSCC Head and Neck Neoplasms Hepatocellular Carcinoma Infections Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Liver Diseases Liver Neoplasms Male Urogenital Diseases Melanoma Merkel Cell Carcinoma NSCLC Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Polyomavirus Infections Rectal Diseases Rectal Neoplasms Renal Cancer Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Squamous Cell Carcinoma of Head and Neck Stomach Diseases Stomach Neoplasms Tumor Virus Infections Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Continue PD-1/PD-L1 Inhibitors treatment

Drug

Continued treatment with PD-1/PD-L1-1 inhibitor

Other names: Keytruda (pembrolizumab), Optiva (nivolumab), Tecentriq (atezolizumab), Yervoy (ipilimumab), LIBTAYO (cemiplimab)

Discontinue PD-1/PD-L1-1 inhibitor

Other

Discontinued treatment with PD-1/PD-L1-1 inhibitor

Primary outcomes

  1. 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.

  2. Progression-free Survival (PFS) (at between 2-3.9 months)

    Time frame: Between 2 months and 3.9 months

    The (median) length of time from the initial date of treatment to the date of documented progression, or the date of death due to any cause (in the absence of progression, whichever occurs first), with progression defined by RECIST v1.1.Per RECIST v1.1, progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least5mm. For non-target lesions, PD: Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression.

  3. Progression-free Survival (PFS) (at between 4-7.9 months)

    Time frame: Between 4 months and 7.9 months

    The (median) length of time from the initial date of treatment to the date of documented progression, or the date of death due to any cause (in the absence of progression, whichever occurs first), with progression defined by RECIST v1.1.Per RECIST v1.1, progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least5mm. For non-target lesions, PD: Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression.

  4. Progression-free Survival (PFS)

    Time frame: Up to 36 months

    The (median) length of time from the initial date of treatment to the date of documented progression, or the date of death due to any cause (in the absence of progression, whichever occurs first), with progression defined by RECIST v1.1.Per RECIST v1.1, progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least5mm. For non-target lesions, PD: Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression.

Secondary outcomes

  1. 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.

  2. Overall Survival (OS)

    Time frame: Up to 36 months

    The length of time from the start of treatment that patients are still alive.

  3. 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).

Sponsors and collaborators

Lead sponsor

Dan Zandberg

Other

Registry information

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Nov 8, 2019
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.