Trial · NCT07134556
Phase II Trial Evaluating the Safety and Efficacy of the Combination of Zimberelimab, Domvanalimab and Sacituzumab Govitecan as 1L Therapy for PD-L1 Positive Advanced TNBC
NCT07134556, Phase 2, Withdrawn, MedSIR
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase II Trial Evaluating the Safety and Efficacy of the Combination of Zimberelimab, Domvanalimab and Sacituzumab Govitecan as 1L Therapy for PD-L1 Positive Advanced TNBC. Trials, record NCT07134556. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07134556
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Trial Evaluating the Safety and Efficacy of the Combination of Zimberelimab, Domvanalimab and Sacituzumab Govitecan as 1L Therapy for PD-L1 Positive Advanced TNBC
- NCT number
- NCT07134556
- Status
- Withdrawn
- Phases
- Phase 2
- Enrollment
- 0 participants, actual
- Lead sponsor
- MedSIR
- Conditions
- Triple Negative Breast Cancer, PDL-1 Positive
- Interventions
- Zimberelimab (AB122), Domvanalimab (DOM), Sacituzumab Govitecan (SG)
- First posted
- 2025-08-21
- Last updated
- 2026-05-01
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy in terms of objective response rate (ORR) as per RECIST v.1.1. | Approximately 1 year | ORR rate defined as the rate of patients with complete response (CR) or partial response (PR) as determined locally by the investigator in accordance RECIST v.1.1. |
| Secondary | Efficacy in terms of PFS as per RECIST v.1.1. | Aproximately 1 year | PFS: period from treatment initiation until the first occurrence of disease progression as determined locally by the investigator assessment using RECIST v.1.1 or death from any cause, whichever occurs first. |
| Secondary | Efficacy in terms of Overall Survival. | Aproximately 1 year | OS: period from treatment initiation until death from any cause. |
| Secondary | Efficacy in terms of Clinical benefit rate (CBR) as per RECIST v.1.1. | Aproximately 1 year | CBR: rate of patients with objective response (CR or PR), or stable disease for at least 24 weeks, as determined locally by the investigator using RECIST v.1.1. |
| Secondary | Efficacy in terms of Time to response (TTR) as per RECIST v.1.1. | Aproximately 1 year | TTR: period from treatment initiation to the first objective tumor response (tumor shrinkage of ≥ 30%) observed for patients who achieved a CR or PR, as determined locally by the investigator using RECIST v.1.1. |
| Secondary | Efficacy in terms of Duration of response (DoR) as per RECIST v.1.1. | Aproximately 1 year | DoR: period from the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first, as determined locally by the investigator using RECIST v.1.1. |
| Secondary | Efficacy in terms of Best percentage of change as per RECIST v.1.1. | Aproximately 1 year | Best percentage of change from baseline in the size of target tumor lesions, defined as the biggest decrease, or smallest increase if no decrease will be observed, as determined locally by the investigator using RECIST v.1.1. |
| Secondary | To evaluate changes in health-related quality-of-life (QoL) | Approximately 1 year | Changes from baseline in the European Organization for Research and Treatment of Cancer (QoL) Questionnaire Core 30 (EORTC QLQ-C30) scale. The EORTC-QLQ-C30 is a 30-item questionnaire, composed of five multi-item functional subscales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global QoL subscale, and six single-item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The questionnaire employs 28 4-point Likert scales with responses from "not at all" to "very much" and two 7-point Likert scales for global health and overall QoL. Responses to all items are then converted to a 0 to 100 scale. For functional and global QoL scales, higher scores represent a better level of functioning/QoL. For symptom-oriented scales, a higher score represents more severe symptoms. |
| Secondary | To evaluate changes in health-related quality-of-life (QoL) | Approximately 1 year. | Changes from baseline in the European Organization for Research and Treatment of Cancer (QoL) Questionnaire BR42 (QLQ-BR42). The EORTC-QLQ-BR42 is a 42-item BC-specific companion module to the EORTCQLQ-C30 and consists of nine multi-item scales that assess body image, sexual functioning, breast satisfaction, systemic therapy side effects, arm symptoms, breast symptoms, endocrine therapy symptoms, skin mucosis symptoms, endocrine sexual symptoms; single items assess sexual enjoyment, future perspective, and feelings about upset by hair loss. |
| Secondary | To determine the safety and toxicity profile of zimberelimab, sacituzumab govitecan and domvalimab treatment. | Approximately 1 year | Safety and tolerability as per NCI-CTCAE v.5.0. Safety assessments will consist of monitoring and recording protocol-defined AEs, SAEs and non-serious adverse event of special interests (AESIs); measurement of protocol-specified hematology, clinical chemistry, measurement of protocol-specified vital signs; and other protocol specified tests that are deemed critical to the safety evaluation of the Study drug(s). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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 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/NCT07134556
GET https://conductscience.org/api/trials/v1/NCT07134556/registered