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Trying to Find the Correct Le...

Trying to Find the Correct Length of Treatment with Immune Checkpoint Therapy

Last Updated: 2025-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-27

Study Completion Date

2030-09-30

Brief Summary

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This phase III trial compares survival in urothelial cancer patients who stop immune checkpoint inhibitor treatment after being treated for about a year to those patients who continue treatment with immune checkpoint inhibitors. Immunotherapy with monoclonal antibodies, such as avelumab, durvalumab, pembrolizumab, atezolizumab, and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Stopping immune checkpoint inhibitors early may still make the tumor shrink and patients may have similar survival rates as the patients who continue treatment. Stopping treatment early may also lead to fewer treatment-related side effects, an improvement in mental health, and a lower cost burden to patients.

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Detailed Description

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PRIMARY OBJECTIVE:

I. To compare overall survival (OS).

SECONDARY OBJECTIVES:

I. To compare progression free survival (PFS) by (Response Evaluation Criteria in Solid Tumors) RECIST 1.1 criteria.

II. To compare PFS by immune-related (ir)RECIST criteria. III. To determine treatment-free interval (TFI) after immune checkpoint inhibitor (ICI) discontinuation. (Arm B) IV. To determine the rate of response by RECIST 1.1 criteria after ICI rechallenge. (Arm B) V. To assess adverse events in each study arm by Common Terminology Criteria for Adverse Events (CTCAE) 5.0.

OUTLINE: Patient are randomized to 1 of 2 arms.

ARM A (CONTINUATION OF ICI TREATMENT): Patients receive either pembrolizumab intravenously (IV) over 30 minutes on day 1, nivolumab IV over 30 minutes on days 1 and 15, atezolizumab IV over 30-60 minutes on day 1, durvalumab IV over 60 minutes on days 1 and 15, or avelumab IV over 60 minutes on days 1 and 15. Cycles repeat every 21 or 42 days for pembrolizumab, every 21 days for atezolizumab, and 28 days for nivolumab, durvalumab, and avelumab in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, starting new treatment or withdrawn consent, patients are followed up at 4 weeks, and then every 6 months for 5 years following registration.

ARM B (DISCONTINUATION OF ICI TREATMENT): Patients receiving ICI treatment will discontinue ICI treatment within 1 cycle length after randomization. Cycle length is determined by the ICI regimen the patient is receiving at randomization. At disease progression patients may restart the same ICI treatment they were receiving upon randomization at physician discretion.

After completion of study treatment, patients are followed up at 4 weeks, and then every 6 months for 5 years following registration.

Conditions

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Locally Advanced Bladder Urothelial Carcinoma Locally Advanced Renal Pelvis Urothelial Carcinoma Locally Advanced Ureter Urothelial Carcinoma Locally Advanced Urethral Urothelial Carcinoma Locally Advanced Urothelial Carcinoma Metastatic Bladder Urothelial Carcinoma Metastatic Renal Pelvis Urothelial Carcinoma Metastatic Ureter Urothelial Carcinoma Metastatic Urethral Urothelial Carcinoma Metastatic Urothelial Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A (immune checkpoint inhibitor)

CONTINUATION OF ICI TREATMENT:

Patients receive either pembrolizumab intravenously (IV) over 30 minutes on day 1, nivolumab IV over 30 minutes on days 1 and 15, atezolizumab IV over 30-60 minutes on day 1, durvalumab IV over 60 minutes on days 1 and 15, or avelumab IV over 60 minutes on days 1 and 15. Cycles repeat every 21 or 42 days for pembrolizumab, every 21 days for atezolizumab, and 28 days for nivolumab, durvalumab, and avelumab in the absence of disease progression or unacceptable toxicity.

Group Type ACTIVE_COMPARATOR

Pembrolizumab

Intervention Type DRUG

Given IV

Nivolumab

Intervention Type DRUG

Given IV

Atezolizumab

Intervention Type DRUG

Given IV

Durvalumab

Intervention Type DRUG

Given IV

Avelumab

Intervention Type DRUG

Given IV

Arm B (immune checkpoint inhibitor)

DISCONTINUATION OF ICI TREATMENT:

Patients receiving ICI treatment will discontinue ICI treatment within 1 cycle length after randomization. Cycle length is determined by the ICI regimen the patient is receiving at randomization. At disease progression patients may restart the same ICI treatment they were receiving upon randomization at physician discretion.

Group Type EXPERIMENTAL

Pembrolizumab

Intervention Type DRUG

Given IV

Nivolumab

Intervention Type DRUG

Given IV

Atezolizumab

Intervention Type DRUG

Given IV

Durvalumab

Intervention Type DRUG

Given IV

Avelumab

Intervention Type DRUG

Given IV

Interventions

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Pembrolizumab

Given IV

Intervention Type DRUG

Nivolumab

Given IV

Intervention Type DRUG

Atezolizumab

Given IV

Intervention Type DRUG

Durvalumab

Given IV

Intervention Type DRUG

Avelumab

Given IV

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with positive HCV antibody are eligible if HCV ribonucleic acid (RNA) polymerase chain reaction (PCR) is negative
* Patients with HIV who are compliant with highly active antiretroviral therapy (HAART) and have normal CD4 count and undetectable viral load are eligible
* No history of allogeneic organ transplantation
* No current immunosuppressive medication exceeding 10 mg/day of prednisone or its equivalent

\* Patients with pre-existing or treatment-emergent autoimmune or inflammatory disorders which do not require systemic immunosuppressive treatment exceeding 10 mg/day of prednisone or its equivalent may be included
* No history of another primary malignancy except for malignancy treated with curative intent with no known active disease for \>= 2 years, and adequately treated non-melanomatous skin cancer or carcinoma in situ (e.g. cervical carcinoma in situ \[CIS\]) without evidence of disease
* No female patients who are pregnant or breastfeeding, or male or female patients of reproductive potential who are not willing to employ effective birth control, because this study involves investigational agents whose genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test pregnancy test done =\< 14 days prior to registration is required

REGISTRATION ELIGIBILITY CRITERIA:

* Patients without progressive disease per RECIST v 1.1 guidelines (i.e., with an ongoing CR, PR or SD) following completion of 12-15 months of ICI treatment
* No toxicity from ICI therapy that makes continuation of treatment clinically unacceptable
* Adequate bone marrow and organ functions to continue PD-1/L1 ICI as judged by the treating physician
* Age \>= 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Central nervous system (CNS) metastasis is allowed if radiographically stable, clinically asymptomatic, and prior local therapy (if received) was completed \> 6 months before registration
* No history of tuberculosis, active hepatitis B (HBV) or hepatitis C (HCV), or uncontrolled human immunodeficiency virus (HIV)

* Patients with resolved HBV infection, defined as positive hepatitis B core antibody (anti-Hb) and negative hepatitis B surface antigen (HbsAg), are eligible
* Patients with positive HCV antibody are eligible if HCV RNA PCR is negative
* Patients with HIV who are compliant with highly active antiretroviral therapy (HAART) and have normal CD4 count and undetectable viral load are eligible

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiao X. Wei, MD, MAS

Role: STUDY_CHAIR

Dana-Farber Cancer Institute

Locations

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