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 : December 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumors NSCLC Bladder Cancer HNSCC Renal Cancer Melanoma Anal Cancer Colorectal Cancer Cholangiocarcinoma Gastric Cancer Hepatocellular Carcinoma||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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 31, 2021|
|Estimated Study Completion Date :||October 31, 2021|
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.
Drug: Continue PD-1/PD-L1 Inhibitors treatment
Continued treatment with PD-1/PD-L1-1 inhibitor
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.
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.
- 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).
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: Daniel Goldstein, BSNfirstname.lastname@example.org|
|Contact: Carrie Muniz, BSNemail@example.com|
|United States, Pennsylvania|
|UPMC Hillman Cancer Center||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15232|
|Contact: Daniel Goldstein, BSN 412-864-7820 firstname.lastname@example.org|
|Contact: Carrie Muniz, BSN 412-623-6121 email@example.com|
|Principal Investigator: Antoinette J Wozniak, MD, FACP|
|Principal Investigator:||Antoinette J Wozniak, MD, FACP||UPMC Hillman Cancer Center|