IRB #

STUDY00016716

Title

(TESARO 4010-01-001) A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an anti-PD-1 Monoclonal Antibody, in Patients with Advanced Solid Tumors

Principal Investigator

Koenraad De Geest

Study Purpose

This is a research study to test a new investigational drug. An investigational drug is one that is not yet approved by any regulatory authorities, such as the United States Food and Drug Administration (FDA). The investigational drug being studied here is called TSR-042, and is an anti-programmed cell death-1 (anti-PD-1) antibody, designed to help the immune system recognize and attack cancer cells.

This is a Phase 1 study that is being carried out in 3 parts; currently, the study is enrolling into the final stage, Part 2B, with a main purpose of evaluating the safety and ability of the investigational drug to reduce the size of tumors in patients with endometrial or ovarian cancer cells containing specific mutations (changes).

Medical Condition(s)

Endometrial cancer
Ovarian Cancer
Microsatellite Instability (MSI)

Eligibility Criteria

1a. Histologically or cytologically proven advanced (unresectable) or metastatic endometrial cancer (all histologies are allowed except endometrial sarcoma), OR
1b. Platinum-resistant ovarian cancer (defined as progression of disease on or <6 months after platinum doublet chemotherapy)

2a (for endometrial cancer): Progression of disease on or after platinum doublet therapy, with no more than 2 lines of prior anti-cancer therapy (hormone therapies do not count toward this number) for recurrent or advanced (≥Stage IIIB) disease, OR
2b (for ovarian cancer): Progression of disease on or <6 months after platinum doublet therapy, with no more than 1 additional systemic therapy after becoming platinum-resistant

3. Tumor microsatellite instability (MSI) and/or polymerase-epsilon (POLE) gene mutation testing result required for all participants
For endometrial cancer: Microsatellite stable (MSS) or microsatellite instability high (MSI-H)
For ovarian cancer: MSI-H or POLE-mutation; microsatellite stable tumors are not eligible

4. Availability of formalin-fixed, paraffin-embedded archival tumor tissue from a previous surgery/biopsy; or, if unavailable, agreement to a new biopsy to obtain a tissue sample from an easily accessible tumor lesion prior to study treatment initiation

Other eligibility criteria will also apply.

Age Range

18 - 99

Healthy Volunteers Needed

No

Duration of Participation

Treatment can continue for up to 2 years, or until disease progression, unacceptable toxicity, patient withdrawal, investigator decision, or death. Continued treatment with the study drug beyond 2 years may be considered following discussion between the investigators and the study sponsor.
After treatment ends, you will be followed for safety assessments every 90 days via telephone.

Minors Included

No

Contact

Yukie Bean, CCRP
Gyn/Onc Study Coordinator
503.418.4522

Sponsor

TESARO, Inc.

Recruitment End

01/01/2021

Compensation Provided

No


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