Trial · NCT02839707
Pegylated Liposomal Doxorubicin Hydrochloride With Atezolizumab and/or Bevacizumab in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
NCT02839707, Phase 2, Phase 3, Active not recruiting, National Cancer Institute (NCI); results first posted 2025-03-04
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Pegylated Liposomal Doxorubicin Hydrochloride With Atezolizumab and/or Bevacizumab in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. Trials, record NCT02839707. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02839707
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pegylated Liposomal Doxorubicin Hydrochloride With Atezolizumab and/or Bevacizumab in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
- NCT number
- NCT02839707
- Status
- Active not recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 444 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Fallopian Tube High Grade Serous Adenocarcinoma, Ovarian High Grade Serous Adenocarcinoma, Ovarian Seromucinous Carcinoma, Primary Peritoneal High Grade Serous Adenocarcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Fallopian Tube Clear Cell Adenocarcinoma, Recurrent Fallopian Tube Endometrioid Adenocarcinoma, Recurrent Fallopian Tube Undifferentiated Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Ovarian Clear Cell Adenocarcinoma, Recurrent Ovarian Endometrioid Adenocarcinoma, Recurrent Ovarian Undifferentiated Carcinoma, Recurrent Platinum-Resistant Fallopian Tube Carcinoma, Recurrent Platinum-Resistant Ovarian Carcinoma, Recurrent Platinum-Resistant Primary Peritoneal Carcinoma, Recurrent Primary Peritoneal Carcinoma, Recurrent Primary Peritoneal Clear Cell Adenocarcinoma, Recurrent Primary Peritoneal Endometrioid Adenocarcinoma, Recurrent Primary Peritoneal Undifferentiated Carcinoma
- Interventions
- Atezolizumab, Bevacizumab, Computed Tomography, Pegylated Liposomal Doxorubicin Hydrochloride, Quality-of-Life Assessment
- First posted
- 2016-07-21
- Last updated
- 2026-10-26
- Results first posted
- 2025-03-04
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Dose Limiting Toxicities (DLT) of Experimental Regimens | Up to 28 days | Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0 (CTCAE version 5.0 will be used beginning April 1, 2018). DLT will be assessed. |
| Primary | Progression Free Survival (PFS) (Phase II) | From study enrollment to the investigator determined date of progression or death due to any cause, whichever occurs first, assessed up to 5 years | Will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria and will include estimates of the hazard ratios and the corresponding confidence intervals for the experimental regimen relative to the reference regimen, as well as Kaplan-Meier estimates of the survivorship function for each treatment group. Progression is defined by a 20% increase in the sum of the longest diameter of target lesions and a 5 mm absolute increase from nadir, or an unequivocal increase in a non-target lesion, or the appearance of new lesions. |
| Primary | PFS (Phase III) | From study enrollment to the investigator determined date of progression or death due to any cause, whichever occurs first, assessed up to 5 years. | Will be assessed by RECIST v1.1 criteria and will include estimates of the hazard ratios and the corresponding confidence intervals for the experimental regimen relative to the reference regimen, as well as Kaplan-Meier estimates of the survivorship function for each treatment group. Progression is defined by a 20% increase in the sum of the longest diameter of target lesions and a 5 mm absolute increase from nadir, or an unequivocal increase in a non-target lesion, or the appearance of new lesions. |
| Primary | Overall Survival (OS) (Phase III) | From study enrollment to the date of death regardless of the cause, assessed up to 5 years | OS will be evaluated by Kaplan Meier methods. The median survival and confidence intervals will be reported. |
| Secondary | Objective Response Rate (ORR) (Partial or Complete Response) (Phase II) | Up to 5 years | Will be assessed by RECIST v1.1 criteria. Will be tabulated by treatment group, and 95% confidence intervals presented using Wilson's Score Method. Treatment arms will be compared using a likelihood ratio chi-square test. Progression is defined by a 20% increase in the sum of the longest diameter of target lesions and a 5 mm absolute increase from nadir, or an unequivocal increase in a non-target lesion, or appearance of new lesions. For the definition of response: the responses are assessed as overall best response during the course of therapy. For partial response (PR), the sum of the longest diameters must decrease by at least 30%. For a complete response (CR), all evidence of disease must be gone and the CA125 levels must normalize. If a patient experiences a disease progression during treatment, this is classified as progressive disease (PD). If the patient neither progresses (PD) nor has a response (CR or PR), then the patient is classified as stable disease (SD). |
| Secondary | ORR (Partial or Complete Response) (Phase III) | Up to 5 years | Will be assessed by RECIST v1.1. Will be tabulated by treatment group, and 95% confidence intervals will be presented using Wilson's Score Method. Treatment arms will be compared using a likelihood ratio chi-square test. Progression is defined by a 20% increase in the sum of the longest diameter of target lesions and a 5 mm absolute increase from nadir, or an unequivocal increase in a non-target lesion, or the appearance of new lesions. For the definition of response: the responses are assessed as overall best response during the course of therapy. For partial response (PR), the sum of the longest diameters must decrease by at least 30%. For a complete response (CR), all evidence of disease must be gone and the CA125 levels must normalize. If a patient experiences a disease progression during treatment, this is classified as progressive disease (PD). If the patient neither progresses (PD) nor has a response (CR or PR), then the patient is classified as stable disease (SD). |
| Secondary | Number of Patients With a Grade 3 (or Higher) Adverse Event (Phase II) | Up to 5 years | CTCAE V5.0 was used to classify adverse events. This endpoint will tabulate the number of patients who reported at least one adverse event of a grade 3 (or higher). |
| Secondary | Number of Patients With a Grade 3 (or Higher) Adverse Event (Phase III) | Up to 5 years | CTCAE V5.0 was used to classify adverse events. This endpoint will tabulate the number of patients who reported at least one adverse event of a grade 3 (or higher). |
| Secondary | Patient Reported Outcomes | Up to 2 years | Patient reported outcomes are measured with the NFOSI-18 Disease-related physical symptoms subscale (DRS-P). The DRS-P subscale comprises 9 items with each item ranging from 0 to 4. The total score of the DRS-P subscale ranges 0 - 36 with a larger score suggesting preferred/better health states. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Dose Limiting Toxicities (DLT) of Experimental Regimens | Up to 28 days | Patients enrolled into safety stage 1 and 2 | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Progression Free Survival (PFS) (Phase II) | From study enrollment to the investigator determined date of progression or death due to any cause, whichever occurs first, assessed up to 5 years | Eligible patients enrolled in Phase I and II. | months | MEDIAN |
| PRIMARY | PFS (Phase III) | From study enrollment to the investigator determined date of progression or death due to any cause, whichever occurs first, assessed up to 5 years. | Eligible patients enrolled in Phase I, II and III. | months | MEDIAN |
| PRIMARY | Overall Survival (OS) (Phase III) | From study enrollment to the date of death regardless of the cause, assessed up to 5 years | Eligible patients enrolled in Phase I, II and III. | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) (Partial or Complete Response) (Phase II) | Up to 5 years | Eligible patients enrolled in Phase I and II. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | ORR (Partial or Complete Response) (Phase III) | Up to 5 years | Eligible patients enrolled in Phase I, II and III. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With a Grade 3 (or Higher) Adverse Event (Phase II) | Up to 5 years | Eligible patients enrolled in safety stage 2 or phase II and received at least one treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With a Grade 3 (or Higher) Adverse Event (Phase III) | Up to 5 years | Eligible patients enrolled in safety stage 2, phase II, and phase III and received at least one treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Patient Reported Outcomes | Up to 2 years | Eligible patients enrolled in Phase I, II and III and provided baseline and at least one follow-up assessments. | score | MEAN |
Source ClinicalTrials.gov
Results by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Dose Limiting Toxicities (DLT) of Experimental Regimens | Arm I (PLD, Atezolizumab) | 0 | Participants | ||
| Incidence of Dose Limiting Toxicities (DLT) of Experimental Regimens | Arm II (PLD, Bevacizumab, Atezolizumab) | 0 | Participants | ||
| Incidence of Dose Limiting Toxicities (DLT) of Experimental Regimens | Arm III (PLD, Bevacizumab) | 0 | Participants | ||
| Progression Free Survival (PFS) (Phase II) | Arm I (PLD, Atezolizumab) | 4.2 | 95% Confidence Interval 3.4 to 5.6 | months | |
| Progression Free Survival (PFS) (Phase II) | Arm II (PLD, Bevacizumab, Atezolizumab) | 7.6 | 95% Confidence Interval 5.6 to 8.8 | months | |
| Progression Free Survival (PFS) (Phase II) | Arm III (PLD, Bevacizumab) | 5.5 | 95% Confidence Interval 3.9 to 7.3 | months | |
| PFS (Phase III) | Arm I (PLD, Atezolizumab) | 4.0 | 95% Confidence Interval 3.3 to 5.6 | months | |
| PFS (Phase III) | Arm II (PLD, Bevacizumab, Atezolizumab) | 7.4 | 95% Confidence Interval 5.7 to 7.8 | months | |
| PFS (Phase III) | Arm III (PLD, Bevacizumab) | 5.6 | 95% Confidence Interval 4.8 to 6.5 | months | |
| Overall Survival (OS) (Phase III) | Arm I (PLD, Atezolizumab) | 14.5 | 95% Confidence Interval 10.7 to 18.7 | months |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase I | STARTED | Arm I (PLD, Atezolizumab) | 17 | |
| Phase I | STARTED | Arm II (PLD, Bevacizumab, Atezolizumab) | 8 | |
| Phase I | STARTED | Arm III (PLD, Bevacizumab) | 8 | |
| Phase I | COMPLETED | Arm I (PLD, Atezolizumab) | 8 | |
| Phase I | COMPLETED | Arm II (PLD, Bevacizumab, Atezolizumab) | 8 | |
| Phase I | COMPLETED | Arm III (PLD, Bevacizumab) | 8 | |
| Phase I | NOT COMPLETED | Arm I (PLD, Atezolizumab) | 9 | |
| Phase I | NOT COMPLETED | Arm II (PLD, Bevacizumab, Atezolizumab) | 0 | |
| Phase I | NOT COMPLETED | Arm III (PLD, Bevacizumab) | 0 | |
| Phase II | STARTED | Arm I (PLD, Atezolizumab) | 80 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events1,416
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 | Anemia | Blood and lymphatic system disorders | Arm I (PLD, Atezolizumab) | 55 | 111 | |
| other | Anemia | Blood and lymphatic system disorders | Arm II (PLD, Bevacizumab, Atezolizumab) | 62 | 160 | |
| other | Anemia | Blood and lymphatic system disorders | Arm III (PLD, Bevacizumab) | 63 | 154 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm I (PLD, Atezolizumab) | 1 | 111 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm II (PLD, Bevacizumab, Atezolizumab) | 2 | 160 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm III (PLD, Bevacizumab) | 1 | 154 | |
| other | Hemolysis | Blood and lymphatic system disorders | Arm I (PLD, Atezolizumab) | 0 | 111 | |
| other | Hemolysis | Blood and lymphatic system disorders | Arm II (PLD, Bevacizumab, Atezolizumab) | 0 | 160 | |
| other | Hemolysis | Blood and lymphatic system disorders | Arm III (PLD, Bevacizumab) | 1 | 154 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Arm I (PLD, Atezolizumab) | 0 | 111 |
1 to 10 of 1,416Source ClinicalTrials.gov
See all 1,416 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (PLD, Atezolizumab) | 104 | 124 |
| Total, all-cause mortality | Arm II (PLD, Bevacizumab, Atezolizumab) | 123 | 160 |
| Total, all-cause mortality | Arm III (PLD, Bevacizumab) | 134 | 160 |
| Total, other adverse events | Arm I (PLD, Atezolizumab) | 106 | 111 |
| Total, other adverse events | Arm II (PLD, Bevacizumab, Atezolizumab) | 159 | 160 |
| Total, other adverse events | Arm III (PLD, Bevacizumab) | 150 | 154 |
| Total, serious adverse events | Arm I (PLD, Atezolizumab) | 44 | 111 |
| Total, serious adverse events | Arm II (PLD, Bevacizumab, Atezolizumab) | 86 | 160 |
| Total, serious adverse events | Arm III (PLD, Bevacizumab) | 73 | 154 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37185961 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA180868 | NRG Oncology Network Group Operations Center | WOLMARK, NORMAN; Le, Quynh-Thu Xuan; MANNEL, ROBERT S. | NRG ONCOLOGY FOUNDATION, INC. | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02839707
GET https://conductscience.org/api/trials/v1/NCT02839707/results?page=2