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A Study of Dostarlimab (TSR-042) Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Patients With Recurrent or Primary Advanced Endometrial Cancer

NCT03981796

Description:

This is a Phase 3, randomized, double-blind, multicenter study to evaluate the efficacy and safety of dostarlimab plus carboplatin-paclitaxel versus placebo plus carboplatin-paclitaxel in patients with recurrent or primary advanced (Stage III or IV) endometrial cancer.

Related Conditions:
  • Endometrial Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study of Dostarlimab (TSR-042) Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Patients With Recurrent or Primary Advanced Endometrial Cancer
  • Official Title: A Phase 3, Randomized, Double-blind, Multicenter Study of Dostarlimab (TSR-042) Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Patients With Recurrent or Primary Advanced Endometrial Cancer

Clinical Trial IDs

  • ORG STUDY ID: 4010-03-001
  • SECONDARY ID: ENGOT-EN6
  • SECONDARY ID: GOG-3031
  • NCT ID: NCT03981796

Conditions

  • Endometrial Cancer

Interventions

DrugSynonymsArms
DostarlimabTSR-042Arm 1
PlaceboArm 2
Carboplatin-paclitaxelArm 1

Purpose

This is a Phase 3, randomized, double-blind, multicenter study to evaluate the efficacy and safety of dostarlimab plus carboplatin-paclitaxel versus placebo plus carboplatin-paclitaxel in patients with recurrent or primary advanced (Stage III or IV) endometrial cancer.

Trial Arms

NameTypeDescriptionInterventions
Arm 1Active ComparatorDostarlimab (TSR-042) plus Carboplatin-paclitaxel
  • Dostarlimab
  • Carboplatin-paclitaxel
Arm 2Placebo ComparatorPlacebo plus Carboplatin-paclitaxel
  • Placebo
  • Carboplatin-paclitaxel

Eligibility Criteria

        Inclusion Criteria:

          -  Female subject is at least 18 years of age.

          -  Subject has histologically or cytologically proven endometrial cancer with recurrent
             or advanced disease.

          -  Subject must have primary Stage III or Stage IV disease or first recurrent endometrial
             cancer with a low potential for cure by radiation therapy or surgery alone or in
             combination.

          -  Subject has an ECOG performance status of 0 or 1.

          -  Subject has adequate organ function.

        Exclusion Criteria:

          -  Subject has received neo-adjuvant/adjuvant systemic chemotherapy for primary Stage III
             or IV disease and:

               1. has not had a recurrence or PD prior to entering the study OR

               2. has had a recurrence or PD within 6 months of completing chemotherapy treatment
                  prior to entering the study

          -  Subject has had > 1 recurrence of endometrial cancer.

          -  Subject has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.

          -  Subject has received prior anticancer therapy within 21 days or < 5 times the
             half-life of the most recent therapy prior to Study Day 1, whichever is shorter.

          -  Subject has a concomitant malignancy, or subject has a prior non-endometrial invasive
             malignancy who has been disease-free for < 3 years or who received any active
             treatment in the last 3 years for that malignancy.

          -  Subject has known uncontrolled central nervous system metastases, carcinomatosis
             meningitis, or both.

          -  Subject has a known history of human immunodeficiency virus.

          -  Subject has known active hepatitis B or hepatitis C.

          -  Subject has an active autoimmune disease that has required systemic treatment in the
             past 2 years.

          -  Subject has a diagnosis of immunodeficiency or is receiving systemic steroid therapy
             or any other form of systemic immunosuppressive therapy within 7 days prior to the
             first dose of study treatment.

          -  Subject has not recovered from cytotoxic therapy-induced AEs.

          -  Subject has not recovered adequately from AEs or complications from any major surgery
             prior to starting therapy.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:To compare the progression-free survival (PFS) of treatment with dostarlimab plus carboplatin-paclitaxel to treatment with placebo plus carboplatin-paclitaxel, as assessed by the Investigator per RECIST v.1.1, in the following:
Time Frame:Up to 5 years
Safety Issue:
Description:All subjects with recurrent or primary advanced endometrial cancer Subjects with microsatellite instability-high (MSI-H) recurrent or primary advanced endometrial cancer

Secondary Outcome Measures

Measure:PFS based on blinded independent central review (BICR)
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Overall survival (OS)
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Objective response rate (ORR)
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Duration of response (DOR)
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Disease control rate (DCR)
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Patient-reported outcomes (PROs) in the European Quality of Life scale, 5-Dimensions, 5-Levels (EQ-5D-5L)
Time Frame:Up to 5 years
Safety Issue:
Description:EQ-5D-5L is a validated questionnaire to assess the overall health-related quality of life in patients across diseases. EQ-5D-5L consists of a descriptive section of 5 questions, one related to each of: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Questions use a 5-point scale ("no problems", "slight problems", "moderate problems", "severe problems", "unable/extreme problems"). Scores are converted to an index value based on country-specific value sets, with a value of 0 representing "death" and 1 representing "perfect health"). The EQ-5D-5L also includes a visual-analogue scale of overall health on a 100-point scale (from "Worst imaginable health state" to "Best imaginable health state").
Measure:Patient-reported outcomes (PROs) in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30 [Core])
Time Frame:Up to 5 years
Safety Issue:
Description:EORTC QLQ-C30 is a validated questionnaire to assess the overall health-related quality of life in patients with cancer and is composed of 30 questions including multi-item scales and single item measures. These include five functional scales (physical, role, emotional, cognitive and social), three symptom scales (fatigue, nausea/vomiting, and pain), a global health status/quality of life scale (GHS/QOL), and six single items (dyspnoea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The QLQ-C30 employs a week recall period for all items and a 4-point scale for the functional and symptom scales/items with response categories "Not at all", "A little", "Quite a bit" and "Very much". The two items assessing GHS/QOL utilize a 7-point scale ranging from 1 ("Very Poor") to 7 ("Excellent"). Scores are averaged, and transformed to a 0-100 scale. A higher score on functional scales represents better function, and on symptom scales represents more severe symptoms.
Measure:Patient-reported outcomes (PROs) in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-EN24 [Endometrial Cancer Module])
Time Frame:Up to 5 years
Safety Issue:
Description:EORTC QLQ-EN24 is a validated questionnaire to assess the overall health-related quality of life in patients with all stages of endometrial cancer, and consists of 24 questions including multi-item scales and single item measures. These include three functional scales (sexual interest, activity, and enjoyment), five symptom scales (lymphoedema, urological symptoms, GI symptoms, poor body image, and sexual/vaginal problems), and five single items (back/pelvis pain, tingling/numbness, muscular pain, hair loss, and taste change). Questions use a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to a 0-100 scale; a higher score represents a more severe overall side effect of treatment.
Measure:Number and percentage of participants experiencing treatment-emergent adverse events (TEAEs)
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Number and percentage of participants with drug-related adverse events (AEs)
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Number and percentage of participants discontinuing study drug due to an adverse event (AE)
Time Frame:Up to 5 years
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Tesaro, Inc.

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