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PD-1 Inhibitor/CTLA-4 Inhibitor
AGEN2034 Alone or With AGEN1884 for Cervical Cancer
Phase 2
Waitlist Available
Research Sponsored by Agenus Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has cervical cancer and has relapsed after a platinum-based treatment (first line) regimen for advanced (recurrent, unresectable, or metastatic) disease.
a. Have measurable disease on imaging based on RECIST version 1.1 by Investigator assessments and independent central radiologic review.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months
Awards & highlights
Study Summary
This trial is testing a new cancer treatment on patients who have already tried other methods. The trial will compare the new treatment to a placebo and to the new treatment combined with another experimental drug.
Who is the study for?
This trial is for adults over 18 with advanced cervical cancer that has worsened after first-line platinum-based chemotherapy. Participants must have a specific type of tumor, measurable disease, good organ function, and an ECOG performance status of 0 or 1. They should not be pregnant, agree to use two barrier methods of contraception if applicable, and provide a tumor tissue sample.Check my eligibility
What is being tested?
The RaPiDS Phase 2 trial tests AGEN2034 alone (monotherapy) or combined with AGEN1884 (combination therapy) in patients with second-line cervical cancer. It's randomized and blinded but doesn't compare the two arms directly; each arm's efficacy is measured against historical controls.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system such as inflammation in various organs, allergic reactions similar to severe hypersensitivity responses, fatigue, potential blood disorders like changes in cell counts which could affect immunity and healing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cervical cancer returned after first-line platinum-based treatment.
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My cancer can be measured on scans according to specific criteria.
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I have a confirmed diagnosis of cervical cancer that cannot be surgically removed.
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My cervical cancer returned after first-line platinum-based treatment.
Select...
My cervical cancer is not one of the excluded types.
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My blood counts meet the required levels without recent transfusions.
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I am expected to live at least 3 more months and can care for myself with minimal assistance.
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I am 18 years old or older.
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My cervical cancer is advanced and cannot be removed by surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate
Secondary outcome measures
Area under the concentration-time curve within time span t1 to t2 at steady-state (AUC(τ1-τ2)-ss)
Area under the drug concentration-time curve from time zero to infinity (AUC(0-∞))
Area under the drug concentration-time curve from time zero to time t (AUC(0-t))
+13 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: AGEN2034 + PlaceboExperimental Treatment1 Intervention
AGEN2034 administered with placebo monotherapy: approximately 100 patients.
Group II: AGEN2034 + AGEN1884Experimental Treatment2 Interventions
AGEN2034 administered in combination with AGEN1884 (combination therapy): approximately 100 patients.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AGEN2034
2017
Completed Phase 2
~220
AGEN1884
2016
Completed Phase 2
~90
Find a Location
Who is running the clinical trial?
Agenus Inc.Lead Sponsor
51 Previous Clinical Trials
4,575 Total Patients Enrolled
GOG FoundationNETWORK
41 Previous Clinical Trials
15,929 Total Patients Enrolled
Medical DirectorStudy DirectorAgenus Inc.
2,777 Previous Clinical Trials
8,063,268 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cervical cancer returned after first-line platinum-based treatment.You have a history of severe allergic reactions to fully human monoclonal antibodies, a history of anaphylaxis, or uncontrolled asthma.You have used illegal drugs or abused alcohol within the last year.My cancer can be measured on scans according to specific criteria.I am not legally allowed to make my own decisions.I am using two reliable forms of birth control during the study.You are already taking part in a research study testing a new medication or device, and it hasn't been at least 4 weeks since you started.I have a confirmed diagnosis of cervical cancer that cannot be surgically removed.I have been diagnosed with HIV.I will not need any cancer treatment other than the trial.I have a tumor or cancer spread in my brain or spinal cord.My cervical cancer returned after first-line platinum-based treatment.You must have a measurable disease that has been confirmed by a central medical facility at the beginning of the trial.I do not have active Hepatitis B, Hepatitis C, or tuberculosis.My cervical cancer is not one of the excluded types.I have at least one measurable tumor to track treatment response.My blood counts meet the required levels without recent transfusions.I have received an organ or tissue transplant from another person.You have mental health or substance abuse disorders that might make it difficult for you to follow the study requirements.I have had more than one treatment for advanced cervical cancer.I have a serious heart condition.I am expected to live at least 3 more months and can care for myself with minimal assistance.I am 18 years old or older.I have an autoimmune disease treated with immunosuppressants in the last 2 years.I have lasting side effects from previous treatments that are moderate to severe.I have or had lung disease or inflammation needing steroids.I have not taken steroids or immunosuppressants in the last 7 days.I agree to join the study and can sign the consent form. I understand that genetic testing is optional.My cervical cancer is advanced and cannot be removed by surgery.I have not had any other type of cancer, with certain exceptions.My organs are functioning well.I am currently receiving IV treatment for an infection.
Research Study Groups:
This trial has the following groups:- Group 1: AGEN2034 + Placebo
- Group 2: AGEN2034 + AGEN1884
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential harm could AGEN2034 pose to study participants?
"Based on the available research, AGEN2034's safety level has been rated a 2. This indicates that there is existing evidence of its security but none in regards to effectiveness."
Answered by AI
Are there any remaining vacancies for participants in this research?
"Clinicaltrials.gov affirms that this research is presently accepting participants, and has been since June 1st 2019 with the last update on October 17th 2022."
Answered by AI
What prior research has been done regarding AGEN2034?
"Presently, there are 7 clinical trials involving AGEN2034. None of these studies is in the concluding Phase 3 stage, but they span 157 sites around Fuenlabrada, Madrid."
Answered by AI
Does this pioneering research represent a unique contribution to the field?
"Presently, there are 7 ongoing investigations into AGEN2034 in 100 cities and 9 countries. Agenus Inc. began researching this drug back in 2019 with a Phase 1 trial involving 195 people; since then, 3 more studies have been concluded successfully."
Answered by AI
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