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Protocol # 16-393

Status

Recruiting

Description

This is a multi-center, open-label, first-in-human Phase 1 study evaluating the anti-programmed death receptor 1 (anti-PD-1) antibody dostarlimab (also known as TSR-042) n participants with advanced solid tumors who have limited available treatment options. The study will be conducted in 2 parts with Part 1 consisting of safety evaluation, pharmacokinetics (PK), and pharmacodynamics (PDy) of escalating doses of dostarlimab. Dose escalation will be based on ascending weight-based dose levels (DLs) of dostarlimab and will continue until the maximum tolerated dose (MTD) is reached or may be stopped at any dose level up to the highest dose of 20 milligrams per kilograms (mg/kg) based on emerging safety and PK/PDy data. Part 2 will be conducted in two subparts, Part 2A (fixed-dose safety evaluation cohorts) and Part 2B (expansion cohorts). Part 2A of the study will evaluate the safety and tolerability of dostarlimab at fixed doses of 500 mg administered every 3 weeks (Q3W) and 1000 mg administered every 6 weeks (Q6W). Part 2B of the study will examine the safety and clinical activity of dostarlimab in cohorts of participants with specific types of advanced solid tumors.

Condition

  • Neoplasms

Interventions

  • Dostarlimab

Phase

Phase 1

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Part 1: Number of participants with treatment emergent AEs (TEAEs)
  • Part 1: Number of participants with immune related AEs of interest
  • Part 1: Number of participants with abnormal hematology parameters
  • Part 1: Number of participants with abnormal clinical chemistry parameters
  • Part 1: Number of participants with abnormal thyroid function
  • Part 1: Number of participants with abnormal urine parameters
  • Part 1: Number of participants with abnormal vital signs
  • Part 1: Number of participants with abnormal electrocardiogram (ECG) parameters
  • Part 1: Number of participants with abnormal physical examination.
  • Part 1: Number of participants receiving concomitant medications
  • Part 2A: Number of participants with TEAEs
  • Part 2A: Number of participants with immune related AEs of interest
  • Part 2A: Number of participants with abnormal hematology parameters
  • Part 2A: Number of participants with abnormal clinical chemistry parameters
  • Part 2A: Number of participants with abnormal thyroid function
  • Part 2A: Number of participants with abnormal urine parameters
  • Part 2A: Number of participants with abnormal vital signs
  • Part 2A: Number of participants with abnormal ECG
  • Part 2A: Number of participants with abnormal physical examination
  • Part 2A: Number of participants receiving concomitant medications
  • Part 2B: Number of participants with TEAEs
  • Part 2B: Number of participants with immune related AEs of interest
  • Part 2B: Number of participants with abnormal hematology parameters
  • Part 2B: Number of participants with abnormal clinical chemistry parameters
  • Part 2B: Number of participants with abnormal thyroid function
  • Part 2B: Number of participants with abnormal urine parameters
  • Part 2B: Number of participants with abnormal vital signs
  • Part 2B: Number of participants with abnormal ECG parameters
  • Part 2B: Number of participants with abnormal physical examination
  • Part 2B: Number of participants receiving concomitant medications
  • Part 2B: Cohort A1 Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • Part 2B: Cohort F ORR by RECIST version 1.1
  • Part 2B: Cohort A2 ORR by RECIST version 1.1
  • Part 2B: Cohort G ORR by RECIST version 1.1
  • Part 2B: Cohort E ORR by immune related Response Evaluation Criteria in Solid Tumors per irRECIST
  • Part 2B: Cohort A1 Duration of response (DOR)
  • Part 2B: Cohort F Duration of response (DOR)
  • Part 2B: Cohort A2 Duration of response (DOR)

Secondary Outcome:

  • Part 2B: Cohort A1 ORR by independent blinded central review using RECIST version 1.1
  • Part 2B: Cohort F ORR by independent blinded central review using RECIST version 1.1
  • Part 2B: Cohort A1 Immune-related objective response rate (irORR) by irRECIST
  • Part 2B: Cohort A2 irORR by irRECIST
  • Part 2B: Cohort F irORR by irRECIST
  • Part 2B: Cohort G irORR by irRECIST
  • Part 2B: Cohort A1 Duration of response (DOR) based on independent blinded central review using RECIST version 1.1
  • Part 2B: Cohort F DOR based on independent blinded central review using RECIST version 1.1
  • Part 2B: Cohort G DOR based on independent blinded central review using RECIST version 1.1
  • Part 2B: Cohort A1 Disease control rate
  • Part 2B: Cohort A2 Disease control rate
  • Part 2B: Cohort F Disease control rate
  • Part 2B: Cohort G Disease control rate
  • Part 2B: Immune related disease control rate
  • Part 2B: Immune related duration of response
  • Part 2B: Progression free survival
  • Part 2B: Overall survival
  • Part 1: Area under the concentration-time curve from time 0 to last (AUC,0-last) assessment of dostarlimab
  • Part 1: Area under the concentration-time curve from time 0 to infinity (AUC, 0-infinity) of dostarlimab
  • Part 1: Minimum concentration (Cmin) of dostarlimab
  • Part 1: Maximum concentration (Cmax) of dostarlimab
  • Part 1: Clearance (CL) of dostarlimab
  • Part 1: Volume of distribution (Vz) of dostarlimab
  • Part 1: Area under the concentration-time curve at steady state (AUC,ss) of dostarlimab
  • Part 1: Minimum concentration at steady state (Cmin,ss) of dostarlimab
  • Part 1: Maximum concentration at steady state (Cmax,ss) of dostarlimab
  • Part 2A : AUC,0-last assessment of dostarlimab
  • Part 2A: AUC, 0-infinity of dostarlimab
  • Part 2A: Cmin of dostarlimab
  • Part 2A: Cmax of dostarlimab
  • Part 2A: CL of dostarlimab
  • Part 2A: Vz of dostarlimab
  • Part 2A: AUC,ss of dostarlimab
  • Part 2A: Cmin,ss of dostarlimab
  • Part 2A: Cmax,ss of dostarlimab
  • Part 2A : AUC,0-last assessment of dostarlimab
  • Part 2A: AUC, 0-infinity of dostarlimab
  • Part 2A: Cmin of dostarlimab
  • Part 2A: Cmax of dostarlimab
  • Part 2A: CL of dostarlimab
  • Part 2A: Vz of dostarlimab
  • Part 2A: AUC,ss of dostarlimab
  • Part 2A: Cmin,ss of dostarlimab
  • Part 2A: Cmax,ss of dostarlimab
  • Part 2B : AUC,0-last assessment of dostarlimab
  • Part 2B: AUC, 0-infinity of dostarlimab
  • Part 2B: Cmin of dostarlimab
  • Part 2B: Cmax of dostarlimab
  • Part 2B: CL of dostarlimab
  • Part 2B: Vz of dostarlimab
  • Part 2B: AUC,ss of dostarlimab
  • Part 2B: Cmin,ss of dostarlimab
  • Part 2B: Cmax,ss of dostarlimab

Enrollment

740

Study Start Date

March 7, 2016

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Tesaro, Inc.

Source

Tesaro, Inc.

Official title

A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an Anti-PD-1 Monoclonal Antibody, in Patients With Advanced Solid Tumors

Clinicaltrials.gov Identifier

NCT02715284

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.