Evaluation of the Length of Treatment With PD-1/PD-L1 Inhibitors in Patients With Advanced Solid Tumors
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ClinicalTrials.gov Identifier: NCT04157985 |
Recruitment Status :
Recruiting
First Posted : November 8, 2019
Last Update Posted : January 12, 2022
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Condition or disease | Intervention/treatment | Phase |
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Advanced Solid Tumors NSCLC Bladder Cancer HNSCC Renal Cancer Melanoma Anal Cancer Colorectal Cancer Cholangiocarcinoma Gastric Cancer Hepatocellular Carcinoma Merkel Cell Carcinoma Cervical Cancer | Drug: Continue PD-1/PD-L1 Inhibitors treatment Other: Discontinue PD-1/PD-L1-1 inhibitor | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 578 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized Non-inferiority Trial Evaluating the Length of Treatment With PD-1/PD-L1 Inhibitors in Patients With Advanced Solid Tumors |
Actual Study Start Date : | November 15, 2019 |
Estimated Primary Completion Date : | October 2026 |
Estimated Study Completion Date : | October 2026 |

Arm | Intervention/treatment |
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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.
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Drug: Continue PD-1/PD-L1 Inhibitors treatment
Continued treatment with PD-1/PD-L1-1 inhibitor
Other Names:
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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.
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Other: Discontinue PD-1/PD-L1-1 inhibitor
Discontinued treatment with PD-1/PD-L1-1 inhibitor |
- 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.
- 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.
- 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.
- 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.
- 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).

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 ± 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04157985
Contact: Ruth Jen, BSN | ruthj2@upmc.edu | ruthj2@upmc.edu |
United States, Pennsylvania | |
UPMC Hillman Cancer Center | Recruiting |
Pittsburgh, Pennsylvania, United States, 15232 | |
Contact: Jennifer Ruth, BSN 412-623-8963 ruthj2@upmc.edu | |
Contact: BSN | |
Principal Investigator: Antoinette J Wozniak, MD, FACP |
Principal Investigator: | Antoinette J Wozniak, MD, FACP | UPMC Hillman Cancer Center |
Responsible Party: | Antoinette J Wozniak, Professor, Department of Otolaryngology, of Immunology, and of Radiation Oncology, University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT04157985 |
Other Study ID Numbers: |
19-135 |
First Posted: | November 8, 2019 Key Record Dates |
Last Update Posted: | January 12, 2022 |
Last Verified: | December 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |
Carcinoma, Merkel Cell Carcinoma Cholangiocarcinoma Anus Neoplasms Kidney Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases |
Intestinal Diseases Rectal Diseases Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Adenocarcinoma Urogenital Neoplasms Urologic Neoplasms Urologic Diseases Rectal Neoplasms Anus Diseases Kidney Diseases Polyomavirus Infections DNA Virus Infections |