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

NCT04157985 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: HCC 19-135
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

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.

Conditions

NSCLC; Bladder Cancer; HNSCC; Renal Cancer; Melanoma; Anal Cancer; Colorectal Cancer; Cholangiocarcinoma; Gastric Cancer; Hepatocellular Carcinoma; Merkel Cell Carcinoma; Cervical Cancer; Advanced Solid Tumors

Outcome Measures

Primary Outcomes (4)

• Time to next treatment

  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.

  Up to 36 months

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

  Between 2 months and 3.9 months

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

  Between 4 months and 7.9 months

• Progression-free Survival (PFS)

  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.

  Up to 36 months

Secondary Outcomes (3)

• 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

Study Arms (2)

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.

Drug: Continue PD-1/PD-L1 Inhibitors 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.

Other: Discontinue PD-1/PD-L1-1 inhibitor

Interventions

Continue PD-1/PD-L1 Inhibitors treatment DRUG

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

Also known as: Keytruda (pembrolizumab), Optiva (nivolumab), Tecentriq (atezolizumab), Yervoy (ipilimumab), LIBTAYO (cemiplimab)

Continue Treatment with PD-1/PD-L1 inhibitor

Discontinue PD-1/PD-L1-1 inhibitor OTHER

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

Discontinue Treatment with PD-1/PD-L1-1 inhibitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dan Zandberg: lead

Study Sites (1)

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Squamous Cell Carcinoma of Head and Neck; Kidney Neoplasms; Melanoma; Anus Neoplasms; Colorectal Neoplasms; Cholangiocarcinoma; Stomach Neoplasms; Carcinoma, Hepatocellular; Carcinoma, Merkel Cell; Uterine Cervical Neoplasms

Interventions

pembrolizumab; Nivolumab; atezolizumab; Ipilimumab; cemiplimab

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Head and Neck Neoplasms; Kidney Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Rectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases; Colonic Diseases; Adenocarcinoma; Stomach Diseases; Liver Neoplasms; Liver Diseases; Polyomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Carcinoma, Neuroendocrine; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Genital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Dan Zandberg, MD

  UPMC Hillman Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 8, 2019
• Study Start: November 15, 2019
• Primary Completion: October 14, 2025
• Study Completion: November 7, 2025
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)