Trial · NCT06964165
A Study Comparing Niraparib Versus Platinum-Taxane Doublet Chemotherapy as Neoadjuvant Treatment in Participants With Homologous Recombination-Deficient Stage III/IV Ovarian Cancer (COHORT-C)
NCT06964165, Phase 2, Terminated, Tesaro, Inc.; results first posted 2025-07-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Comparing Niraparib Versus Platinum-Taxane Doublet Chemotherapy as Neoadjuvant Treatment in Participants With Homologous Recombination-Deficient Stage III/IV Ovarian Cancer (COHORT-C). Trials, record NCT06964165. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06964165
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Comparing Niraparib Versus Platinum-Taxane Doublet Chemotherapy as Neoadjuvant Treatment in Participants With Homologous Recombination-Deficient Stage III/IV Ovarian Cancer (COHORT-C)
- NCT number
- NCT06964165
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 36 participants, actual
- Lead sponsor
- Tesaro, Inc.
- Conditions
- Ovarian Neoplasms
- Interventions
- Niraparib, Carboplatin, Paclitaxel
- First posted
- 2025-05-09
- Last updated
- 2025-11-26
- Results first posted
- 2025-07-15
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pre-Interval Debulking Surgery (IDS) Unconfirmed Overall Response Rate (ORR) | Up to approximately 102 weeks | Pre-IDS unconfirmed ORR is defined as the percentage of participants with unconfirmed complete or partial response on study treatment pre-IDS as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by the Investigator. Complete Response (CR) is defined as disappearance of all target and non target lesions and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters |
| Secondary | Number of Participants With Cancer Antigen (CA)-125 Progression by Gynecological Cancer InterGroup (GCIG) CA-125 Response Criteria | At week 24 | Serum samples were collected to assess CA-125 progression based on the GCIG CA-125 response criteria, which is defined as follows: Criteria 1 - For participants with elevated CA-125 levels pre-treatment that reduced to the normal range during the study, progression is defined as CA-125 ≥2× Upper limit of normal (ULN) on 2 occasions at least 1 week apart.; Criteria 2 - For participants with elevated CA-125 levels pre-treatment that did not reduce to the normal range during the study, progression is defined as CA-125 ≥2× the nadir value on 2 occasions at least 1 week apart.; Criteria 3 - For participants with CA-125 levels in the normal range pre-treatment, progression is defined as CA-125 ≥2× ULN on 2 occasions at least 1 week apart. |
| Secondary | Progression Free Survival (PFS) | Up to approximately 154 weeks | PFS is defined as the time from the date of treatment randomization to the date of first documentation of disease progression (PD) per RECIST v1.1 or death by any cause, whichever occurs first, as determined by the Investigator. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5mm. |
| Secondary | Overall Survival (OS) | Up to approximately 154 weeks | OS is defined as the time from the date of treatment randomization to the date of death by any cause. |
| Secondary | Time to First Subsequent Treatment (TFST) | Up to approximately 154 weeks | TFST is defined as the time from the date of treatment randomization to the date of first subsequent anticancer therapy or death. |
| Secondary | Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Baseline (Predose), Day 8 and 15 of Cycle 1; Day 1, 8 and 15 of Cycle 2 and Cycle 3; Pre-IDS Evaluation, and End of Treatment (Up to approximately 154 weeks). | The PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicity in participants of cancer clinical studies. It characterizes the frequency and severity of adverse events using a standardized scoring system. Responses include 0 ("never" OR "none" OR "Not at all"); 1 ("Rarely" OR "Mild" OR "A little bit"); 2 ("Occasionally" OR "Moderate" OR "Somewhat"); 3 ("Frequently" OR "Severe" OR "Quite a bit") and 4 ("almost constantly" OR "very severe" OR "Very much"), with a higher score indicating a higher frequency and severity of adverse events. |
| Secondary | Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5 | Baseline (Predose), Day 8 and 15 of Cycle 1; Day 1, 8, and 15 of Cycle 2 and Cycle 3; Pre-IDS Evaluation, and End of Treatment (Up to approximately 154 weeks) | The FACT-GP5 item is a single item from the FACT-G that assesses how bothersome the side effects of treatment are for participants with cancer. It evaluates the extent to which side effects of treatment are bothersome for cancer participants. This outcome is measured using a 5-category response scale, where responses include 0="Not at all," 1="A little bit," 2="Somewhat," 3="Quite a bit," and 4="Very much." A higher score on this measure indicates that the participant experiences a greater level of bother from the side effects of treatment. |
| Secondary | Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire | Baseline (Predose), Day 1 of Cycle 2 and Cycle 3; Pre-IDS Evaluation, and End of Treatment (Up to approximately 154 weeks). | EORTC IL136 includes items from the EORTC QLQ-C30, a 30-item survey assessing health-related quality of life (HRQoL) in cancer patients, featuring 5 functional scales, 3 symptom scales, 6 single items, and a global health status/HRQoL scale. Functional and symptom scales/items are rated on 4-point scale with options "Not at all," "A little," "Quite a bit," and "Very much". 2 items measuring global health status/quality of life use a 7-point scale ranging from 1 ("Very Poor") to 7 ("Excellent"). Each item has a specific scoring system, and scores were transformed to a 0-100 scale, where higher scores on functional scales and global health status/HRQoL scale indicate better functioning or quality of life, while higher scores on symptom scales/items indicate greater symptom burden. Baseline is defined as the latest assessment with a non-missing value prior to Cycle 1 Day 1 (C1D1), including those from unscheduled visits. |
| Secondary | Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 137 (EORTC IL137) Questionnaire | Baseline (Predose), Day 1 of Cycle 2 and Cycle 3; Pre-IDS Evaluation, and End of Treatment (Up to approximately 154 weeks). | The OC module (QLQ-OV28) supplements the QLQ-C30 and was designed for participants with local or advanced disease who receive treatment by surgery with or without chemotherapy. It consists of 28 items including 3 functional scales (body image, sexuality, attitude to disease/treatment burden) and 5 symptom scales/items (abdominal/gastrointestinal symptoms, peripheral neuropathy, hormonal/menopausal symptoms, other chemotherapy side effects, and hair loss). A subset of 9 questions will be utilized for this cohort, referred to as the EORTC IL137. The scoring approach is identical to the EORTC QLQ-C30. Scores are transformed to a 0-100 scale, where higher functional scale scores indicate better functioning, and higher symptom scale scores indicate greater symptom burden. Baseline is defined as the latest assessment with a non-missing value prior to C1D1, including unscheduled visits. |
| Secondary | Number of Participants With Treatment Emergent (TE) Non-serious Adverse Events (Non-SAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Treatment Emergent (TE) Special Interest (AESIs) by Severity | Up to approximately 154 weeks | An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, is life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, is a congenital anomaly/birth defect, other situations and is associated with liver injury or impaired liver function. SAEs are subsets of AEs. TEAE is an event that emerged during treatment having been absent pretreatment or worsened relative to the pretreatment state. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pre-Interval Debulking Surgery (IDS) Unconfirmed Overall Response Rate (ORR) | Up to approximately 102 weeks | Intent-to-Treat population included all randomized participants whether or not randomized treatment was administered. | Percentage of Participants | NUMBER |
| SECONDARY | Number of Participants With Cancer Antigen (CA)-125 Progression by Gynecological Cancer InterGroup (GCIG) CA-125 Response Criteria | At week 24 | Intent-to-Treat population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression Free Survival (PFS) | Up to approximately 154 weeks | As pre-specified in Section 2 of the Statistical Analysis Plan, analyses was not performed due to low maturity (\<30%) for PFS data, resulting from insufficient number of participants with events within the length of follow-up in assessing the number of events. | ||
| SECONDARY | Overall Survival (OS) | Up to approximately 154 weeks | As pre-specified in Section 2 of the Statistical Analysis Plan, analyses was not performed due to low maturity (\<30%) for OS data, resulting from insufficient number of participants with events within the length of follow-up in assessing the number of events. | ||
| SECONDARY | Time to First Subsequent Treatment (TFST) | Up to approximately 154 weeks | As pre-specified in Section 2 of the Statistical Analysis Plan, analyses was not performed due to low maturity (\<30%) for TFST data, resulting from insufficient number of participants with events within the length of follow-up in assessing the number of events. | ||
| SECONDARY | Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Baseline (Predose), Day 8 and 15 of Cycle 1; Day 1, 8 and 15 of Cycle 2 and Cycle 3; Pre-IDS Evaluation, and End of Treatment (Up to approximately 154 weeks). | Intent to Treat Population is included as the Overall Number of Participants Analyzed. 'Number Analyzed' refers to participants evaluable at the specified time points. The 0 participants analyzed represents that data was not collected or available for analysis at that particular time point for the respective Arms/Groups. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5 | Baseline (Predose), Day 8 and 15 of Cycle 1; Day 1, 8, and 15 of Cycle 2 and Cycle 3; Pre-IDS Evaluation, and End of Treatment (Up to approximately 154 weeks) | Intent to Treat Population is included as the Overall Number of Participants Analyzed. 'Number Analyzed' refers to participants evaluable at the specified time points. The 0 participants analyzed represents that data was not collected or available for analysis at that particular time point for the respective Arms/Groups. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire | Baseline (Predose), Day 1 of Cycle 2 and Cycle 3; Pre-IDS Evaluation, and End of Treatment (Up to approximately 154 weeks). | Intent to Treat Population is included as the Overall Number of Participants Analyzed. 'Number Analyzed' refers to participants evaluable at the specified time points. The 0 participants analyzed represents that data was not collected or available for analysis at that particular time point for the respective Arms/Groups. | Scores on scale | MEAN |
| SECONDARY | Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 137 (EORTC IL137) Questionnaire | Baseline (Predose), Day 1 of Cycle 2 and Cycle 3; Pre-IDS Evaluation, and End of Treatment (Up to approximately 154 weeks). | Intent to Treat Population is included as the Overall Number of Participants Analyzed. 'Number Analyzed' refers to participants evaluable at the specified time points. The 0 participants analyzed represents that data was not collected or available for analysis at that particular time point for the respective Arms/Groups. | Scores on scale | MEAN |
| SECONDARY | Number of Participants With Treatment Emergent (TE) Non-serious Adverse Events (Non-SAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Treatment Emergent (TE) Special Interest (AESIs) by Severity | Up to approximately 154 weeks | Safety population included all randomized participants who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group2,616
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pre-Interval Debulking Surgery (IDS) Unconfirmed Overall Response Rate (ORR) | Platinum-taxane | 70.6 | 95% Confidence Interval 44.04 to 89.69 | Percentage of Participants | |
| Pre-Interval Debulking Surgery (IDS) Unconfirmed Overall Response Rate (ORR) | Niraparib | 31.6 | 95% Confidence Interval 16.34 to 67.71 | Percentage of Participants | |
| Number of Participants With Cancer Antigen (CA)-125 Progression by Gynecological Cancer InterGroup (GCIG) CA-125 Response Criteria | Platinum-taxane | Criteria 1 | 0 | Participants | |
| Number of Participants With Cancer Antigen (CA)-125 Progression by Gynecological Cancer InterGroup (GCIG) CA-125 Response Criteria | Niraparib | Criteria 1 | 0 | Participants | |
| Number of Participants With Cancer Antigen (CA)-125 Progression by Gynecological Cancer InterGroup (GCIG) CA-125 Response Criteria | Platinum-taxane | Criteria 2 | 0 | Participants | |
| Number of Participants With Cancer Antigen (CA)-125 Progression by Gynecological Cancer InterGroup (GCIG) CA-125 Response Criteria | Niraparib | Criteria 2 | 0 | Participants | |
| Number of Participants With Cancer Antigen (CA)-125 Progression by Gynecological Cancer InterGroup (GCIG) CA-125 Response Criteria | Platinum-taxane | Criteria 3 | 0 | Participants | |
| Number of Participants With Cancer Antigen (CA)-125 Progression by Gynecological Cancer InterGroup (GCIG) CA-125 Response Criteria | Niraparib | Criteria 3 | 0 | Participants | |
| Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Platinum-taxane | Probs Tasting Food/Drink, Baseline, Severity, 0=None | 10 | Participants | |
| Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Niraparib | Probs Tasting Food/Drink, Baseline, Severity, 0=None | 9 | Participants |
1 to 10 of 2,616Source ClinicalTrials.gov
See all 2,616 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Platinum-taxane | 17 | |
| Overall Study | STARTED | Niraparib | 19 | |
| Overall Study | COMPLETED | Platinum-taxane | 0 | |
| Overall Study | COMPLETED | Niraparib | 0 | |
| Overall Study | NOT COMPLETED | Platinum-taxane | 17 | |
| Overall Study | NOT COMPLETED | Niraparib | 19 |
Source ClinicalTrials.gov
Adverse events436
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 | Anaemia | Blood and lymphatic system disorders | Platinum-taxane | 11 | 17 | 40 |
| other | Anaemia | Blood and lymphatic system disorders | Niraparib | 10 | 19 | 24 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Platinum-taxane | 1 | 17 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Niraparib | 0 | 19 | 0 |
| other | Leukocytosis | Blood and lymphatic system disorders | Platinum-taxane | 1 | 17 | 5 |
| other | Leukocytosis | Blood and lymphatic system disorders | Niraparib | 0 | 19 | 0 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Platinum-taxane | 1 | 17 | 1 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Niraparib | 0 | 19 | 0 |
| other | Lymphopenia | Blood and lymphatic system disorders | Platinum-taxane | 1 | 17 | 1 |
| other | Lymphopenia | Blood and lymphatic system disorders | Niraparib | 0 | 19 | 0 |
1 to 10 of 436Source ClinicalTrials.gov
See all 436 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Platinum-taxane | 4 | 17 |
| Total, all-cause mortality | Niraparib | 4 | 19 |
| Total, other adverse events | Platinum-taxane | 17 | 17 |
| Total, other adverse events | Niraparib | 19 | 19 |
| Total, serious adverse events | Platinum-taxane | 4 | 17 |
| Total, serious adverse events | Niraparib | 2 | 19 |
Source ClinicalTrials.gov
Papers0
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Platinum-taxane vs Niraparib: deaths from any cause | Trial comparisons |
| Platinum-taxane vs Niraparib: serious adverse events | 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/NCT06964165
GET https://conductscience.org/api/trials/v1/NCT06964165/results?page=2