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Monoclonal Antibodies
Sacituzumab Govitecan for Cervical Cancer
Phase 2
Recruiting
Led By Alessandro D. Santin, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 years
Awards & highlights
No Placebo-Only Group
Summary
This trial studies an antibody drug to treat recurrent or persistent cervical cancer.
Who is the study for?
This trial is for adults with recurrent or persistent cervical cancer who have had at least one chemotherapy regimen. They must not be pregnant, breastfeeding, or have other invasive cancers in the last 5 years. Participants need functioning major organs and controlled health conditions without significant heart disease, infections, or uncontrolled hypertension.
What is being tested?
The study tests Sacituzumab Govitecan (IMMU-132) on patients with cervical cancer that has come back or hasn't gone away after treatment. It's a Phase 2 trial where all participants receive the drug; there's no comparison group.
What are the potential side effects?
Potential side effects include allergic reactions to the drug components, issues from previous treatments like irinotecan toxicity if experienced before, and general risks associated with chemotherapy such as fatigue, nausea, and lowered blood cell counts.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Objective Response Rate (ORR)
Secondary study objectives
Assess the safety profile of sacituzumab govitecan in cervical cancer patients (adverse events as assessed by CTCAE v5.0)
Durable disease control rate (DDCR)
Duration of overall survival (OS)
+1 moreSide effects data
From 2020 Phase 3 trial • 529 Patients • NCT0257445540%
Fatigue
30%
Nausea
27%
Anaemia
25%
Neutropenia
23%
Constipation
21%
Decreased appetite
20%
Neutrophil count decreased
18%
Cough
18%
Dyspnoea
17%
Diarrhoea
16%
Alopecia
16%
Vomiting
13%
Hypokalaemia
13%
Headache
13%
Back pain
13%
Asthenia
12%
Pyrexia
12%
Aspartate aminotransferase increased
11%
Oedema peripheral
11%
Neuropathy peripheral
10%
Alanine aminotransferase increased
10%
White blood cell count decreased
8%
Urinary tract infection
8%
Myalgia
8%
Pain in extremity
7%
Platelet count decreased
7%
Arthralgia
7%
Dizziness
7%
Abdominal pain
7%
Weight decreased
6%
Mucosal inflammation
6%
Lymphocyte count decreased
6%
Bone pain
6%
Hypomagnesaemia
6%
Hypertension
6%
Thrombocytopenia
6%
Stomatitis
5%
Insomnia
5%
Pain
5%
Rash
5%
Blood alkaline phosphatase increased
5%
Hyperglycaemia
4%
Oropharyngeal pain
4%
Hypophosphataemia
4%
Anxiety
4%
Abdominal pain upper
4%
Breast pain
3%
Upper respiratory tract infection
3%
Musculoskeletal chest pain
3%
Dysgeusia
3%
Lymphoedema
3%
Pruritus
3%
Pleural effusion
3%
Gastrooesophageal reflux disease
3%
Chills
2%
Nasopharyngitis
2%
Hypocalcaemia
2%
Febrile neutropenia
2%
Sepsis
2%
Pneumonia
1%
Nasal congestion
1%
Dyspnoea exertional
1%
Dry skin
1%
Rash maculo-papular
1%
Pericardial effusion
1%
Pulmonary embolism
1%
Respiratory failure
1%
Cellulitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment of Physician's Choice (TPC)
Sacituzumab Govitecan
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Sacituzumab GovitecanExperimental Treatment1 Intervention
Sacituzumab govitecan, 10 mg/kg for the first 2 weeks of 21-day cycle until progression or adverse effects prohibit further treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sacituzumab govitecan
2017
Completed Phase 3
~530
Find a Location
Who is running the clinical trial?
Gilead SciencesIndustry Sponsor
1,130 Previous Clinical Trials
867,107 Total Patients Enrolled
Yale UniversityLead Sponsor
1,920 Previous Clinical Trials
3,040,375 Total Patients Enrolled
Alessandro SantinLead Sponsor
3 Previous Clinical Trials
120 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had an intestinal blockage in the last 6 months.I have been treated with topoisomerase I inhibitors before.I have HIV with a detectable viral load or take medication that affects SN-38 metabolism.I am 18 years old or older.I have had at most 2 chemotherapy treatments for my cervical cancer.I am not on any medication that is not allowed in the study.I haven't had any cancer except for skin cancer or cervical pre-cancer in the last 5 years.I have an uncontrolled seizure disorder or active neurological disease.I have a bleeding disorder or condition that causes excessive bleeding.I have moderate to severe loss of appetite, nausea, vomiting, or signs of a blocked intestine.I can provide a sample of my tumor for testing.My cancer has formed a large tumor or mass.I have had a severe allergic reaction or major side effects to irinotecan.I have had serious heart problems in the last 6 months.My cervical cancer has returned or persisted after at least one chemotherapy treatment.My surgery removed most or all of my tumor.It has been over 2 weeks since my last treatment or major surgery.I have recovered from major side effects of my last treatment.My cancer can be measured by tests or scans.I stopped taking high dose steroids more than 2 weeks ago.I had immunotherapy before but it's been 4 weeks since my last treatment.I have had severe lung problems like COPD in the last 6 months.My cancer has come back and can be measured.I have cancer that has spread to my brain or its coverings.My chemotherapy during initial radiation for cervical cancer doesn't count as a treatment for persistent or recurrent cancer.I am in good physical condition, have normal kidney, liver, and bone marrow function, and have signed a consent form.
Research Study Groups:
This trial has the following groups:- Group 1: Sacituzumab Govitecan
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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