Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Digestive System Diseases

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Peritoneal Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Abdominal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Peritoneal Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

CRS-207 administered in 3-week cycles.

\* CRS-207 (1 x 10e9 colony forming units \[CFU\]) administered by intravenous (IV) infusion. For Cycle 1 through Cycle 6, CRS-207 will be administered on Day 1 of each cycle. After 6 cycles, CRS-207 will be administered on Day 1 once every 6 weeks (every other cycle).

CRS-207 administered in 3-week cycles, IDO administered twice daily (BID).

* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
* IDO (100 milligrams \[mg\]) administered by mouth (PO) BID, starting on Day 2 of the first CRS-207 treatment cycle.

CRS-207 administered in 3-week cycles, IDO administered BID.

* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
* IDO (300 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.

CRS-207 and pembrolizumab (pembro) administered in 3-week cycles, IDO administered BID.

* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
* Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
* IDO (300 mg) administered PO BID, starting on Day 3 of the first CRS-207 treatment cycle.

CRS-207 and pembro administered in 3-week cycles.

* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
* Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.

CRS-207

Epacadostat

This 2-part, Phase 1/2 study will test investigational cancer drugs known as CRS-207, epacadostat (IDO), and pembrolizumab (pembro). The purpose of this study is to find out how safe it is to give the investigational drugs to women with platinum-resistant ovarian, fallopian tube, or peritoneal cancer and if it helps patients with these types of cancer live longer or can help shrink or slow the growth of cancer.

Safety and Efficacy of CRS-207 With Epacadostat in Platinum Resistant Ovarian, Fallopian or Peritoneal Cancer

A Phase 1/2, Open-Label Safety and Efficacy Evaluation of CRS-207 in Combination With Epacadostat in Adults With Platinum-Resistant Ovarian, Fallopian, or Peritoneal Cancer

Count of subjects in the Phase 1 cohorts who reported a hematologic and/or non-hematologic DLT. Non-hematological DLTs are defined as follows, excluding the safety events specified for exemption in Section 5.3.1 of the study protocol:

* any treatment-emergent adverse event (TEAE) not attributable to disease or disease-related processes that occurs during the DLT observation period (Cycle 1) and is Grade 3 or higher according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4;
* any use of systemic steroids; and/or
* a study drug dose interruption lasting ≥ 7 days for an adverse event with an unclear relationship to study drug.

Hematological DLTs are defined as:

* Grade 4 neutropenia lasting \>7 days;
* Grade ≥3 febrile neutropenia;
* Grade 4 anemia;
* Grade 4 thrombocytopenia or ≥ Grade 3 thrombocytopenia lasting \>7 days or associated with bleeding; and/or
* Dose delay \>7 days secondary to myelosuppression.

Count of subjects in the Phase 1 cohorts with incidences of CTCAE Grade 3 or higher AEs.

Count of subjects in the Phase 2 cohorts with incidences of AEs.

ORR was evaluated for Phase 2 subjects based upon the best overall response (BOR) for individual study subjects. BOR was determined by the highest post-baseline qualitative response value for each assessed subject as measured by modified response evaluation criteria in solid tumors (mRECIST) and given the following hierarchy of overall response results: complete response (CR) \> partial response (PR) \> stable disease (SD) \> progressive disease (PD) \> not evaluable (NE). The protocol-specified ORR was defined as the percentage of evaluable subjects with a BOR of CR or PR; however, this percentage was not calculated per the final study Statistical Analysis Plan (SAP). Therefore, the number of evaluable subjects with BOR mRECIST values of CR, PR, SD, PD, and NE are provided for this outcome measure.

Number of weeks from the date of first dose of study treatment to the first date of objectively determined progressive disease (PD) or death from any cause, estimated using Kaplan-Meier (KM) methods with 95% confidence intervals (CIs). PD is determined by mRECIST.

ORR was evaluated for Phase 1 subjects based upon the best overall response (BOR) for individual study subjects. BOR was determined by the highest post-baseline qualitative response value for each assessed subject as measured by modified response evaluation criteria in solid tumors (mRECIST), RECIST v1.1, and GCIG CA-125 criteria and given the following hierarchy of overall response results: complete response (CR) \> partial response (PR) \> stable disease (SD) \> progressive disease (PD) \> not evaluable (NE). The protocol-specified ORR was defined as the percentage of evaluable subjects with a BOR of CR or PR; however, this percentage was not calculated per the final study Statistical Analysis Plan (SAP). Therefore, the number of evaluable subjects with BOR mRECIST values of CR, PR, SD, PD, and NE are provided for this outcome measure.

Number of weeks from the date of first dose of study treatment to the first date of objectively determined progressive disease (PD) or death due to any cause, estimated using Kaplan-Meier (KM) methods with 95% confidence intervals (CIs). PD is determined by mRECIST, RECIST v1.1, and GCIG CA-125.

The protocol-specified DCR was defined as the percentage of evaluable subjects with a BOR of CR or PR, or SD as determined by mRECIST, RECIST v1.1, and GCIG CA-125 criteria.

Number of weeks from date of CR or PR designation until PD designation, as determined by mRECIST, RECIST v1.1 and GCIG CA-125 criteria.

Number of weeks from the date of first dose of study treatment to the date of death from any cause, estimated using KM methods with 95% CIs for subjects in the SAF. Subjects without documentation of death at the time of analysis were censored as of the date the subject was last known to be alive. For subjects lost to follow up, the last visit or last contact date where the subject is documented to be alive will be used to estimate last known date alive.

Incyte Corporation

Aduro Biotech, Inc.

AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.

CRS-207 administered in 3-week cycles.

\* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 will be administered on Day 1 of each cycle. After 6 cycles, CRS-207 will be administered on Day 1 once every 6 weeks (every other cycle).

Phase 1: CRS-207

CRS-207 administered in 3-week cycles, IDO administered BID.

* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
* IDO (100 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.

Phase 1: CRS-207/IDO 100 mg

Phase 1: CRS-207/IDO 300 mg

CRS-207 and pembro administered in 3-week cycles, IDO administered BID.

* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
* Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
* IDO (300 mg) administered PO BID, starting on Day 3 of the first CRS-207 treatment cycle.

Phase 2: CRS-207/Pembro/IDO

Phase 2: CRS-207/Pembro

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Canada

United States

Region of Enrollment

Baseline analysis provided for all subjects who were administered at least 1 dose of protocol-specified drug (the Safety Analysis Set \[SAF\]).

Study was terminated early and included a small number of subjects, and insufficient data were available to evaluate the clinical activity of the study treatment. Due to low enrollment, some protocol-specified outcome measures were not evaluated.

Medical Affairs

Analysis performed on subjects in the Phase 1 safety analysis set (SAF).

Phase 1: Number of Subjects Reporting Hematologic and/or Non-hematologic Dose-limiting Toxicity (DLT)

Analysis performed on subjects in the Phase 1 safety analysis set.

Phase 1: Adverse Events (AEs) by CTCAE Grade 3 or Higher

Analysis performed on subjects in the Phase 2 safety analysis set.

Phase 2: Adverse Events (AEs)

Analysis performed on subjects in the SAF who had ≥1 post-baseline response assessment. One subject in the Phase 2 SAF did not complete ≥1 post-baseline response assessment and was therefore not evaluated for this outcome measure.

Phase 2: Objective Response Rate (ORR)

Analysis performed on subjects in the SAF who had ≥1 post-baseline response assessment. Three subjects in the Phase 1 SAF did not complete ≥1 post-baseline response assessment and were therefore not evaluated for this outcome measure.

Phase 1: Objective Response Rate (ORR) by mRECIST

Analysis performed on subjects in the Phase 1 SAF.

Phase 1: Progression Free Survival (PFS)

Complete Response (CR)

Partial Response (PR)

Stable Disease (SD)

Analysis performed on subjects in the Phase 1 and Phase 2 SAF.

Disease Control Rate (DCR)

No study subjects achieved CR or PR designation; therefore, per the final SAP DOR was not derived.

Duration of Response (DOR)

Overall Survival (OS)

Analysis performed on subjects in the Phase 2 SAF.

Phase 2: Progression Free Survival (PFS)

CRS-207 administered in 3-week cycles, epacadostat (IDO) administered twice daily (BID).

* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
* IDO (100 milligrams \[mg\]) administered by mouth (PO) BID, starting on Day 2 of the first CRS-207 treatment cycle.

Spots Global Cancer Trial Database for Safety and Efficacy of CRS-207 With Epacadostat in Platinum Resistant Ovarian, Fallopian or Peritoneal Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial