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Monoclonal Antibodies

Sacituzumab Govitecan + Pembrolizumab for Triple-Negative Breast Cancer (ASCENT-04 Trial)

Phase 3
Recruiting
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Individuals must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria as evaluated locally
Must not have
Received prior therapy with an agent directed to another stimulatory or coinhibitory T-cell receptor
Have active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomization up to approximately 53 months
Awards & highlights

Summary

This trial is testing a new cancer drug against a standard cancer drug, to see if the new drug helps people with a certain type of breast cancer live longer without the cancer getting worse.

Who is the study for?
This trial is for adults with advanced triple-negative breast cancer that hasn't been treated yet and tests positive for PD-L1. They must have measurable disease, agree to use contraception if of childbearing potential, and have an ECOG performance status of 0 or 1. Those with HIV can join if it's well-controlled on ART.Check my eligibility
What is being tested?
The study compares the effectiveness of Sacituzumab Govitecan-hziy (SG) combined with Pembrolizumab versus a physician-chosen treatment paired with Pembrolizumab in extending the time patients live without their cancer getting worse.See study design
What are the potential side effects?
Potential side effects include allergic reactions, lowered blood cell counts leading to increased infection risk or bleeding problems, fatigue, nausea, hair loss from chemotherapy drugs like Paclitaxel and possible liver or kidney issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer can be measured on scans according to specific criteria.
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My breast cancer is advanced, can't be removed by surgery, hasn't been treated before for this stage, and is PD-L1 positive.
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My triple-negative breast cancer is PD-L1 positive.
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I have triple-negative breast cancer that has spread from the start.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated with drugs targeting immune cells before.
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I have an active hepatitis B or C infection.
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I have an autoimmune disease treated with medication in the last 2 years.
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I am currently taking antibiotics for a serious infection.
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I have been treated with drugs targeting DNA replication in cancer cells.
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I am HIV positive and have had Kaposi sarcoma or Multicentric Castleman Disease.
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I have another type of cancer that is currently active.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomization up to approximately 53 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization up to approximately 53 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Secondary outcome measures
Duration of Response (DOR) as Assessed by BICR per RECIST Version 1.1
Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1
Overall Survival (OS)
+8 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Sacituzumab Govitecan-hziy (SG) + PembrolizumabExperimental Treatment2 Interventions
Participants will receive SG 10 mg/kg on Days 1 and 8 of 21-day cycles and pembrolizumab 200 mg on Day 1 of 21-day cycles Pembrolizumab will be administered for a maximum of 35 cycles.
Group II: Pembrolizumab + Treatment of Physician's Choice (TPC)Active Control5 Interventions
Participants will receive pembrolizumab 200 mg on Day 1 of each 21-day cycle (maximum 35 cycles) plus TPC determined prior to randomization from 1 of the 3 allowed regimens: Paclitaxel 90 mg/m^2 on Days 1, 8, and 15 of 28-day cycles nab-Paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of 28-day cycles Gemcitabine 1000 mg/m^2 + carboplatin area under the curve (AUC) 2 on Days 1 and 8 of 21-day cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sacituzumab govitecan
FDA approved
Pembrolizumab
FDA approved

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Sacituzumab Govitecan-Hziy is an antibody-drug conjugate that targets Trop-2, delivering a cytotoxic agent directly to cancer cells, while Pembrolizumab is a PD-1 inhibitor that blocks the interaction between PD-1 on T cells and PD-L1 on tumor cells, enhancing the immune system's ability to attack the cancer. These treatments are significant for PD-L1 positive patients as they provide targeted approaches to either directly kill cancer cells or boost the immune response against them, potentially improving treatment efficacy.
Anti-PD-1 therapy for clinical treatment of lymphoma: a single-arm meta-analysis.

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor
1,086 Previous Clinical Trials
847,990 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,919 Previous Clinical Trials
5,067,823 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
343 Previous Clinical Trials
186,140 Total Patients Enrolled

Media Library

Pembrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05382286 — Phase 3
Programmed Death-Ligand 1 Positive Research Study Groups: Pembrolizumab + Treatment of Physician's Choice (TPC), Sacituzumab Govitecan-hziy (SG) + Pembrolizumab
Programmed Death-Ligand 1 Positive Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT05382286 — Phase 3
Pembrolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05382286 — Phase 3
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