Trial · NCT02575807
Safety and Efficacy of CRS-207 With Epacadostat in Platinum Resistant Ovarian, Fallopian or Peritoneal Cancer
NCT02575807, Phase 1, Phase 2, Terminated, Aduro Biotech, Inc.; results first posted 2019-04-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of CRS-207 With Epacadostat in Platinum Resistant Ovarian, Fallopian or Peritoneal Cancer. Trials, record NCT02575807. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02575807
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of CRS-207 With Epacadostat in Platinum Resistant Ovarian, Fallopian or Peritoneal Cancer
- NCT number
- NCT02575807
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 35 participants, actual
- Lead sponsor
- Aduro Biotech, Inc.
- Conditions
- Platinum-resistant Ovarian Cancer, Platinum-resistant Fallopian Cancer, Platinum-resistant Peritoneal Cancer
- Interventions
- CRS-207, Epacadostat, Pembrolizumab
- First posted
- 2015-10-15
- Last updated
- 2019-04-04
- Results first posted
- 2019-04-04
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1: Number of Subjects Reporting Hematologic and/or Non-hematologic Dose-limiting Toxicity (DLT) | Subjects followed for DLTs for 21 days following the first dose of CRS-207 (treatment Cycle 1 for CRS-207). | 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. |
| Primary | Phase 1: Adverse Events (AEs) by CTCAE Grade 3 or Higher | Subjects followed from the start of study treatment until 30 days following the final dose of study drug, an average of 3 months. | Count of subjects in the Phase 1 cohorts with incidences of CTCAE Grade 3 or higher AEs. |
| Primary | Phase 2: Adverse Events (AEs) | Subjects followed from the start of study treatment until 30 days following the final dose of study drug, an average of 2 months. | Count of subjects in the Phase 2 cohorts with incidences of AEs. |
| Primary | Phase 2: Objective Response Rate (ORR) | BOR was assessed from the first dose of study treatment until documented disease progression, initiation of a new cancer treatment, death, or study termination, whichever comes first, assessed up to 20 weeks. | 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. |
| Primary | Phase 2: Progression Free Survival (PFS) | Subjects followed for disease progression from first dose of study treatment until 30 days after last dose of study treatment or initiation of new cancer treatment, whichever comes first, assessed up to 20 weeks. | 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. |
| Secondary | Phase 1: Objective Response Rate (ORR) by mRECIST | BOR was assessed from the first dose of study treatment until documented disease progression, starting of a new cancer treatment, death, or study termination, whichever is earlier, assessed up to 100 weeks. | 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. |
| Secondary | Phase 1: Progression Free Survival (PFS) | Subjects followed for disease progression from first dose of study treatment until 30 days after last dose of study treatment or initiation of new cancer treatment, whichever comes first, assessed up to 100 weeks | 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. |
| Secondary | Disease Control Rate (DCR) | BOR was assessed from the first dose of study treatment until documented disease progression, starting of a new cancer treatment, death, or study termination, whichever comes first, assessed up to 100 weeks. | 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. |
| Secondary | Duration of Response (DOR) | Subjects followed for disease progression from date of CR or PR designation until documented disease progression or study termination, whichever comes first, assessed up to 100 weeks. | 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. |
| Secondary | Overall Survival (OS) | OS was assessed from the first dose of study treatment until death or study termination, whichever comes first, assessed up to 100 weeks. | 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1: Number of Subjects Reporting Hematologic and/or Non-hematologic Dose-limiting Toxicity (DLT) | Subjects followed for DLTs for 21 days following the first dose of CRS-207 (treatment Cycle 1 for CRS-207). | Analysis performed on subjects in the Phase 1 safety analysis set (SAF). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 1: Adverse Events (AEs) by CTCAE Grade 3 or Higher | Subjects followed from the start of study treatment until 30 days following the final dose of study drug, an average of 3 months. | Analysis performed on subjects in the Phase 1 safety analysis set. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 2: Adverse Events (AEs) | Subjects followed from the start of study treatment until 30 days following the final dose of study drug, an average of 2 months. | Analysis performed on subjects in the Phase 2 safety analysis set. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 2: Objective Response Rate (ORR) | BOR was assessed from the first dose of study treatment until documented disease progression, initiation of a new cancer treatment, death, or study termination, whichever comes first, assessed up to 20 weeks. | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase 1: Objective Response Rate (ORR) by mRECIST | BOR was assessed from the first dose of study treatment until documented disease progression, starting of a new cancer treatment, death, or study termination, whichever is earlier, assessed up to 100 weeks. | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase 1: Progression Free Survival (PFS) | Subjects followed for disease progression from first dose of study treatment until 30 days after last dose of study treatment or initiation of new cancer treatment, whichever comes first, assessed up to 100 weeks | Analysis performed on subjects in the Phase 1 SAF. | weeks | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) | BOR was assessed from the first dose of study treatment until documented disease progression, starting of a new cancer treatment, death, or study termination, whichever comes first, assessed up to 100 weeks. | Analysis performed on subjects in the Phase 1 and Phase 2 SAF. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response (DOR) | Subjects followed for disease progression from date of CR or PR designation until documented disease progression or study termination, whichever comes first, assessed up to 100 weeks. | No study subjects achieved CR or PR designation; therefore, per the final SAP DOR was not derived. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival (OS) | OS was assessed from the first dose of study treatment until death or study termination, whichever comes first, assessed up to 100 weeks. | Analysis performed on subjects in the Phase 1 and Phase 2 SAF. | weeks | MEDIAN |
| PRIMARY | Phase 2: Progression Free Survival (PFS) | Subjects followed for disease progression from first dose of study treatment until 30 days after last dose of study treatment or initiation of new cancer treatment, whichever comes first, assessed up to 20 weeks. | Analysis performed on subjects in the Phase 2 SAF. | weeks | MEDIAN |
Source ClinicalTrials.gov
Results by group63
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase 1: Number of Subjects Reporting Hematologic and/or Non-hematologic Dose-limiting Toxicity (DLT) | Phase 1: CRS-207 | 1 | Participants | ||
| Phase 1: Number of Subjects Reporting Hematologic and/or Non-hematologic Dose-limiting Toxicity (DLT) | Phase 1: CRS-207/IDO 100 mg | 0 | Participants | ||
| Phase 1: Number of Subjects Reporting Hematologic and/or Non-hematologic Dose-limiting Toxicity (DLT) | Phase 1: CRS-207/IDO 300 mg | 1 | Participants | ||
| Phase 1: Adverse Events (AEs) by CTCAE Grade 3 or Higher | Phase 1: CRS-207 | 6 | Participants | ||
| Phase 1: Adverse Events (AEs) by CTCAE Grade 3 or Higher | Phase 1: CRS-207/IDO 100 mg | 3 | Participants | ||
| Phase 1: Adverse Events (AEs) by CTCAE Grade 3 or Higher | Phase 1: CRS-207/IDO 300 mg | 14 | Participants | ||
| Phase 2: Adverse Events (AEs) | Phase 2: CRS-207/Pembro/IDO | 1 | Participants | ||
| Phase 2: Adverse Events (AEs) | Phase 2: CRS-207/Pembro | 3 | Participants | ||
| Phase 2: Objective Response Rate (ORR) | Phase 2: CRS-207/Pembro/IDO | Complete Response | 0 | Participants | |
| Phase 2: Objective Response Rate (ORR) | Phase 2: CRS-207/Pembro | Complete Response | 0 | Participants |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 1: CRS-207 | 9 | |
| Overall Study | STARTED | Phase 1: CRS-207/IDO 100 mg | 4 | |
| Overall Study | STARTED | Phase 1: CRS-207/IDO 300 mg | 16 | |
| Overall Study | STARTED | Phase 2: CRS-207/Pembro/IDO | 2 | |
| Overall Study | STARTED | Phase 2: CRS-207/Pembro | 4 | |
| Overall Study | Treated | Phase 1: CRS-207 | 8 | |
| Overall Study | Treated | Phase 1: CRS-207/IDO 100 mg | 4 | |
| Overall Study | Treated | Phase 1: CRS-207/IDO 300 mg | 16 | |
| Overall Study | Treated | Phase 2: CRS-207/Pembro/IDO | 1 | |
| Overall Study | Treated | Phase 2: CRS-207/Pembro | 3 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events790
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Phase 1: CRS-207 | 6 | 8 | |
| other | Nausea | Gastrointestinal disorders | Phase 1: CRS-207/IDO 100 mg | 1 | 4 | |
| other | Nausea | Gastrointestinal disorders | Phase 1: CRS-207/IDO 300 mg | 10 | 16 | |
| other | Nausea | Gastrointestinal disorders | Phase 2: CRS-207/Pembro/IDO | 0 | 1 | |
| other | Nausea | Gastrointestinal disorders | Phase 2: CRS-207/Pembro | 1 | 3 | |
| other | Vomiting | Gastrointestinal disorders | Phase 1: CRS-207 | 6 | 8 | |
| other | Vomiting | Gastrointestinal disorders | Phase 1: CRS-207/IDO 100 mg | 1 | 4 | |
| other | Vomiting | Gastrointestinal disorders | Phase 1: CRS-207/IDO 300 mg | 9 | 16 | |
| other | Vomiting | Gastrointestinal disorders | Phase 2: CRS-207/Pembro/IDO | 0 | 1 | |
| other | Vomiting | Gastrointestinal disorders | Phase 2: CRS-207/Pembro | 0 | 3 |
1 to 10 of 790Source ClinicalTrials.gov
See all 790 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1: CRS-207 | 8 | 8 |
| Total, all-cause mortality | Phase 1: CRS-207/IDO 100 mg | 3 | 4 |
| Total, all-cause mortality | Phase 1: CRS-207/IDO 300 mg | 7 | 16 |
| Total, all-cause mortality | Phase 2: CRS-207/Pembro/IDO | 1 | 1 |
| Total, all-cause mortality | Phase 2: CRS-207/Pembro | 1 | 3 |
| Total, other adverse events | Phase 1: CRS-207 | 8 | 8 |
| Total, other adverse events | Phase 1: CRS-207/IDO 100 mg | 4 | 4 |
| Total, other adverse events | Phase 1: CRS-207/IDO 300 mg | 16 | 16 |
| Total, other adverse events | Phase 2: CRS-207/Pembro/IDO | 1 | 1 |
| Total, other adverse events | Phase 2: CRS-207/Pembro | 3 | 3 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Phase 2: CRS-207/Pembro/IDO vs Phase 2: CRS-207/Pembro: Phase 2: Adverse Events (AEs) |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02575807
GET https://conductscience.org/api/trials/v1/NCT02575807/results?page=2