Trial · NCT02963831
A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies
NCT02963831, Phase 1, Phase 2, Completed, Ludwig Institute for Cancer Research; results first posted 2022-12-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies. Trials, record NCT02963831. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02963831
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies
- NCT number
- NCT02963831
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 67 participants, actual
- Lead sponsor
- Ludwig Institute for Cancer Research
- Conditions
- Colorectal Cancer, Ovarian Cancer, Appendiceal Cancer
- Interventions
- ONCOS-102, Durvalumab, Cyclophosphamide
- First posted
- 2016-11-15
- Last updated
- 2022-12-22
- Results first posted
- 2022-12-22
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Dose Limiting Toxicities (DLTs) | up to 31 months (90 days after the last dose of study medication). | All Adverse events (AEs) were coded using the Medical Dictionary for Regulatory Activities (MedDRA) Version 19.0 and classified by MedDRA system organ class (SOC) and preferred term. The severity of AEs was assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03. Adverse events (AEs) were reported based on clinical laboratory tests, vital signs, physical examinations, and any other medically indicated assessments, including subject interviews, from the time informed consent was signed through 90 days after the last dose of study treatment. TEAEs are those that occurred or worsened after administration of the first dose of study treatment. Deaths within the AE Reporting Period included all deaths that occurred during the study treatment period, or up to 90 days after the administration of the last dose of study drug or initiation of a new treatment. |
| Primary | Progression-free Survival (PFS) at Week 24 as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Up to 24 weeks | Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening (up to 28 days before the first dose of study treatment), at cycles 3, 5, 7, 9, and 11 during study treatment, and during on-study follow-up starting 8 weeks after the last disease assessment. Per RECIST 1.1, target lesions were categorized as follows: complete response (CR): disappearance of all target lesions; partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; PD: ≥ 20% increase in the sum of the longest diameter of target lesions; stable disease (SD): small changes that do not meet above criteria. PFS was measured from the date of the first dose of study treatment to the date of earliest disease progression or to the date of death, if disease progression does not occur. Per RECIST 1.1, progressive disease (PD) is defined as a ≥ 20% increase in the sum of the longest diameter of target lesions or the development of new lesions. |
| Secondary | Median Progression-free Survival (PFS) as Measured by Response Evaluation in Solid Tumors 1.1 (RECIST 1.1) Using Kaplan-Meier Method | Up to 29 months | Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening (up to 28 days before the first dose of study treatment), at cycles 3, 5, 7, 9, and 11 during study treatment, and during on-study follow-up starting 8 weeks after the last disease assessment. Per RECIST 1.1, target lesions were categorized as follows: complete response (CR): disappearance of all target lesions; partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; PD: ≥ 20% increase in the sum of the longest diameter of target lesions; stable disease (SD): small changes that do not meet above criteria. PFS was measured from the date of the first dose of study treatment to the date of earliest disease progression or to the date of death, if disease progression does not occur. Per RECIST 1.1, progressive disease (PD) is defined as a ≥ 20% increase in the sum of the longest diameter of target lesions or the development of new lesions. |
| Secondary | Objective Response Rate as Measured by as Measured by Response Evaluation in Solid Tumors 1.1 (RECIST 1.1) | Up to 15 months | Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening (up to 28 days before the first dose of study treatment), at cycles 3, 5, 7, 9, and 11 during study treatment, and during on-study follow-up starting 8 weeks after the last disease assessment. Per RECIST 1.1, target lesions were categorized as follows: complete response (CR): disappearance of all target lesions; partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; PD: ≥ 20% increase in the sum of the longest diameter of target lesions; stable disease (SD): small changes that do not meet above criteria. |
| Secondary | Progression-free Survival (PFS) at Week 24 as Measured by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) | Up to 24 Weeks | Tumor responses were evaluated using appropriate imaging and categorized according to irRECIST at Screening (up to 28 days before the first dose of study treatment), at cycles 3, 5, 7, 9, and 11 during study treatment, and during on-study follow-up starting 8 weeks after the last disease assessment. Per irRECIST, measurable lesions were categorized as follows: immune-related complete response (irCR): Complete disappearance of all target lesions; immune-related partial response (irPR): ≥ 30% decrease from baseline in the Total Measurable Tumor Burden (TMTB); immune-related progressive disease (irPD): ≥ 20% increase from nadir in TMTB; immune-related stable disease (irSD): not meeting above criteria. PFS was measured from the date of the first dose of study treatment to the date of earliest disease progression or to the date of death, if disease progression does not occur. Per irRECIST, irPD is defined as a ≥ 20% increase from nadir in the TMTB. |
| Secondary | Median Progression-free Survival (PFS) by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) as Estimated Using the Kaplan-Meier Method | Up to 39 months | Tumor responses were evaluated using appropriate imaging and categorized according to irRECIST at Screening (up to 28 days before the first dose of study treatment), at cycles 3, 5,7, 9, and 11 during study treatment, and during on-study follow-up starting 8 weeks after the last disease assessment. Per irRECIST, measurable lesions were categorized as follows: immune-related complete response (irCR): Complete disappearance of all target lesions; immune-related partial response (irPR): ≥ 30% decrease from baseline in the total measurable tumor burden (TMTB); immune-related progressive disease (irPD): ≥ 20% increase from nadir in TMTB; immune-related stable disease (irSD): not meeting above criteria. PFS was measured from the date of the first dose of study treatment to the date of earliest disease progression or to the date of death, if disease progression does not occur. Per irRECIST, irPD is defined as a ≥ 20% increase from nadir in the TMTB. |
| Secondary | Objective Response Rate as Measured by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) | Up to 15 months | Tumor responses were evaluated using appropriate imaging and categorized according to irRECIST at Screening (up to 28 days before the first dose of study treatment), at cycles 3, 5, 7, 9, and 11 during study treatment, and during on-study follow-up starting 8 weeks after the last disease assessment. Per irRECIST, measurable lesions were categorized as follows: immune-related complete response (irCR): Complete disappearance of all target lesions; immune-related partial response (irPR): ≥ 30% decrease from baseline in the total measurable tumor burden (TMTB); immune-related progressive disease (irPD): ≥ 20% increase from nadir in TMTB; immune-related stable disease (irSD): not meeting above criteria. |
| Secondary | Median Overall Survival (OS) as Estimated Using the Kaplan-Meier Method | Up to 39 months | After completion of treatment, all subjects were followed for survival every 6 months up to 3 years following initiation of study treatment or until June 25, 2022 when all post-study follow-up was completed. OS was measured from the date of the first dose of study treatment to the date of death or last follow-up (June 25, 2022 when the last follow-up data was collected or earlier). Subjects lost to follow-up are censored on the date when they were last known to be alive. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Dose Limiting Toxicities (DLTs) | up to 31 months (90 days after the last dose of study medication). | All subjects who received at least one dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Progression-free Survival (PFS) at Week 24 as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Up to 24 weeks | All subjects who received at least one dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Median Progression-free Survival (PFS) as Measured by Response Evaluation in Solid Tumors 1.1 (RECIST 1.1) Using Kaplan-Meier Method | Up to 29 months | All subjects who received at least one dose of study medication. | months | MEDIAN |
| SECONDARY | Objective Response Rate as Measured by as Measured by Response Evaluation in Solid Tumors 1.1 (RECIST 1.1) | Up to 15 months | All subjects who received at least one dose of study medication and had a baseline and at least one post-baseline disease assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-free Survival (PFS) at Week 24 as Measured by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) | Up to 24 Weeks | All subjects who received at least one dose of study medication and had a baseline and at least one post-baseline disease assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Median Progression-free Survival (PFS) by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) as Estimated Using the Kaplan-Meier Method | Up to 39 months | All subjects who received at least one dose of study medication. | months | MEDIAN |
| SECONDARY | Objective Response Rate as Measured by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) | Up to 15 months | All subjects who received at least one dose of study medication and had a baseline and at least one post-baseline disease assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Median Overall Survival (OS) as Estimated Using the Kaplan-Meier Method | Up to 39 months | All subjects who received at least one dose of study medication. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group88
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Dose Limiting Toxicities (DLTs) | Cohort A: ONCOS-102 Dose Escalation | Treatment-emergent Adverse Event (TEAE) | 4 | Participants | |
| Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Dose Limiting Toxicities (DLTs) | Cohort B ONCOS-102 Dose Escalation | Treatment-emergent Adverse Event (TEAE) | 5 | Participants | |
| Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Dose Limiting Toxicities (DLTs) | Cohort 1: Epithelial Ovarian Cancer | Treatment-emergent Adverse Event (TEAE) | 19 | Participants | |
| Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Dose Limiting Toxicities (DLTs) | Cohort 2: Metastatic Colorectal Cancer | Treatment-emergent Adverse Event (TEAE) | 36 | Participants | |
| Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Dose Limiting Toxicities (DLTs) | Cohort A: ONCOS-102 Dose Escalation | Treatment-related Adverse Event (TRAE) | 4 | Participants | |
| Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Dose Limiting Toxicities (DLTs) | Cohort B ONCOS-102 Dose Escalation | Treatment-related Adverse Event (TRAE) | 5 | Participants | |
| Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Dose Limiting Toxicities (DLTs) | Cohort 1: Epithelial Ovarian Cancer | Treatment-related Adverse Event (TRAE) | 17 | Participants | |
| Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Dose Limiting Toxicities (DLTs) | Cohort 2: Metastatic Colorectal Cancer | Treatment-related Adverse Event (TRAE) | 30 | Participants | |
| Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Dose Limiting Toxicities (DLTs) | Cohort A: ONCOS-102 Dose Escalation | Serious Adverse Event (SAE) | 3 | Participants | |
| Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Dose Limiting Toxicities (DLTs) | Cohort B ONCOS-102 Dose Escalation | Serious Adverse Event (SAE) | 3 | Participants |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A: ONCOS-102 Dose Escalation | 4 | |
| Overall Study | STARTED | Cohort B: ONCOS-102 Dose Escalation | 5 | |
| Overall Study | STARTED | Cohort 1: Epithelial Ovarian Cancer | 19 | |
| Overall Study | STARTED | Cohort 2: Metastatic Colorectal Cancer | 36 | |
| Overall Study | COMPLETED | Cohort A: ONCOS-102 Dose Escalation | 0 | |
| Overall Study | COMPLETED | Cohort B: ONCOS-102 Dose Escalation | 1 | |
| Overall Study | COMPLETED | Cohort 1: Epithelial Ovarian Cancer | 0 | |
| Overall Study | COMPLETED | Cohort 2: Metastatic Colorectal Cancer | 1 | |
| Overall Study | NOT COMPLETED | Cohort A: ONCOS-102 Dose Escalation | 4 | |
| Overall Study | NOT COMPLETED | Cohort B: ONCOS-102 Dose Escalation | 4 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events836
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 | Cohort A: ONCOS-102 Dose Escalation | 3 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort B ONCOS-102 Dose Escalation | 2 | 5 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 1: Epithelial Ovarian Cancer | 3 | 19 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2: Metastatic Colorectal Cancer | 5 | 36 | |
| other | Neutropenia | Blood and lymphatic system disorders | Cohort A: ONCOS-102 Dose Escalation | 0 | 4 | |
| other | Neutropenia | Blood and lymphatic system disorders | Cohort B ONCOS-102 Dose Escalation | 0 | 5 | |
| other | Neutropenia | Blood and lymphatic system disorders | Cohort 1: Epithelial Ovarian Cancer | 1 | 19 | |
| other | Neutropenia | Blood and lymphatic system disorders | Cohort 2: Metastatic Colorectal Cancer | 1 | 36 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Cohort A: ONCOS-102 Dose Escalation | 0 | 4 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Cohort B ONCOS-102 Dose Escalation | 0 | 5 |
1 to 10 of 836Source ClinicalTrials.gov
See all 836 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A: ONCOS-102 Dose Escalation | 3 | 4 |
| Total, all-cause mortality | Cohort B ONCOS-102 Dose Escalation | 3 | 5 |
| Total, all-cause mortality | Cohort 1: Epithelial Ovarian Cancer | 16 | 19 |
| Total, all-cause mortality | Cohort 2: Metastatic Colorectal Cancer | 28 | 36 |
| Total, other adverse events | Cohort A: ONCOS-102 Dose Escalation | 4 | 4 |
| Total, other adverse events | Cohort B ONCOS-102 Dose Escalation | 5 | 5 |
| Total, other adverse events | Cohort 1: Epithelial Ovarian Cancer | 19 | 19 |
| Total, other adverse events | Cohort 2: Metastatic Colorectal Cancer | 36 | 36 |
| Total, serious adverse events | Cohort A: ONCOS-102 Dose Escalation | 3 | 4 |
| Total, serious adverse events | Cohort B ONCOS-102 Dose Escalation | 3 | 5 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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 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/NCT02963831
GET https://conductscience.org/api/trials/v1/NCT02963831/results?page=2