Description:
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.
Title
- Brief Title: Evaluation of the Length of Treatment With PD-1/PD-L1 Inhibitors in Patients With Advanced Solid Tumors
- Official Title: A Randomized Non-inferiority Trial Evaluating the Length of Treatment With PD-1/PD-L1 Inhibitors in Patients With Advanced Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
19-135
- NCT ID:
NCT04157985
Conditions
- Advanced Solid Tumors
- NSCLC
- Bladder Cancer
- HNSCC
- Renal Cancer
- Melanoma
- Anal Cancer
- Colorectal Cancer
- Cholangiocarcinoma
- Gastric Cancer
- Hepatocellular Carcinoma
Interventions
| Drug | Synonyms | Arms |
|---|
| Continue PD-1/PD-L1 Inhibitors treatment | Keytruda (pembrolizumab), Optiva (nivolumab), Tecentriq (atezolizumab), Yervoy (ipilimumab) | Continue Treatment with PD-1/PD-L1 inhibitor |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| 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. | - 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. | |
Eligibility Criteria
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.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Time to next treatment |
| Time Frame: | Up to 36 months |
| Safety Issue: | |
| Description: | 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. |
Secondary Outcome Measures
| Measure: | Incidence of irAEs (Immune-Related Adverse Events) |
| Time Frame: | Up to 36 months |
| Safety Issue: | |
| Description: | 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. |
| Measure: | Overall Survival (OS) |
| Time Frame: | Up to 36 months |
| Safety Issue: | |
| Description: | The length of time from the start of treatment that patients are still alive. |
| Measure: | Best Objective Response (BOR) |
| Time Frame: | Up to 36 months |
| Safety Issue: | |
| Description: | 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). |
Details
| Phase: | Phase 3 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Antoinette J Wozniak |
Last Updated
December 17, 2020
