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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomization up to approximately 53 months
Awards & highlights
ASCENT-04 Trial 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.
ASCENT-04 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My cancer can be measured on scans according to specific criteria.
Select...
My breast cancer is advanced, can't be removed by surgery, hasn't been treated before for this stage, and is PD-L1 positive.
Select...
My triple-negative breast cancer is PD-L1 positive.
Select...
I have triple-negative breast cancer that has spread from the start.
ASCENT-04 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ randomization up to approximately 53 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomization up to approximately 53 months
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 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
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%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
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
ASCENT-04 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
Find a Location
Who is running the clinical trial?
Gilead SciencesLead Sponsor
1,084 Previous Clinical Trials
843,039 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,054,655 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
343 Previous Clinical Trials
186,253 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My breast cancer is advanced, can't be removed by surgery, hasn't been treated before for advanced disease, and is PD-L1 positive.I have triple-negative breast cancer that has spread from the start.I agree to use birth control as required by the study.My cancer can be measured on scans according to specific criteria.I agree to use birth control as required by the study.I have been treated with drugs targeting immune cells before.I am fully active or restricted in physically strenuous activity but can do light work.I have an active hepatitis B or C infection.I finished my breast cancer treatment over 6 months ago and now have a recurrence.My cancer can be measured on scans according to specific criteria.My organs are functioning well.I have an autoimmune disease treated with medication in the last 2 years.I am currently taking antibiotics for a serious infection.I haven't had cancer treatment (except hormone therapy) in the last 6 months or radiation in the last 2 weeks.I have been treated with drugs targeting DNA replication in cancer cells.I am HIV positive and have had Kaposi sarcoma or Multicentric Castleman Disease.I have HIV, am on ART, and my infection is well-controlled.My breast cancer is advanced, can't be removed by surgery, hasn't been treated before for this stage, and is PD-L1 positive.I have another type of cancer that is currently active.I haven't been in a study for new treatments or devices in the last 4 weeks.My triple-negative breast cancer is PD-L1 positive.I have triple-negative breast cancer that has spread from the start.It seems like the criterion is incomplete. Can you please provide more details or context so I can assist you accurately?I have HIV, am on ART, and my infection is well-controlled.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab + Treatment of Physician's Choice (TPC)
- Group 2: Sacituzumab Govitecan-hziy (SG) + Pembrolizumab
Awards:
This trial has 4 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Federal Drug Administration given Pembrolizumab its stamp of approval?
"Pembrolizumab has received a score of 3 for safety. This is because it is in Phase 3 clinical trials, meaning that there are data to support its efficacy and multiple rounds of data supporting its safety."
Answered by AI
How many people fit the eligibility criteria for this clinical trial?
"440 patients that meet the detailed requirements are needed for this research project to move forward as planned. Gilead Sciences, the organisation sponsoring the trial, will be based out of multiple locations including Fort Myers, Florida and Houston University's MD Anderson Cancer Center."
Answered by AI
Are there any unfilled vacancies for this research project?
"That is correct, the online information does show that this clinical trial is still recruiting patients. The original posting was on 7/25/2022 and the most recent update was on 9/5/2022. In total, 24 different medical facilities are participating and 440 patients are needed for the study."
Answered by AI
Can you tell me how many hospitals are participating in this research project?
"This trial has 24 recruiting sites, which are located in Fort Myers, Houston, Papillion, and other places."
Answered by AI
Who else is applying?
What state do they live in?
New Jersey
New York
What site did they apply to?
Northside Hospital,228 Riverstone Dr.
New York Cancer & Blood Specialists - Port Jeffers,12 East 86th St, Suite 4
Beth Israel Deaconess Medical Center
Other
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I see its good for me and i know its more personalice.
PatientReceived 1 prior treatment
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