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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.
Must not have
Is legally incapacitated or has limited legal capacity.
Has known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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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.
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My cervical cancer is not one of the excluded types.
Select...
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not legally allowed to make my own decisions.
Select...
I have been diagnosed with HIV.
Select...
I have a tumor or cancer spread in my brain or spinal cord.
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I do not have active Hepatitis B, Hepatitis C, or tuberculosis.
Select...
I have received an organ or tissue transplant from another person.
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I have had more than one treatment for advanced cervical cancer.
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I have a serious heart condition.
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I have lasting side effects from previous treatments that are moderate to severe.
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I have or had lung disease or inflammation needing steroids.
Select...
I am currently receiving IV treatment for an infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 months for reporting.

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
Secondary study objectives
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 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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
52 Previous Clinical Trials
4,604 Total Patients Enrolled
GOG FoundationNETWORK
46 Previous Clinical Trials
17,438 Total Patients Enrolled
Medical DirectorStudy DirectorAgenus Inc.
2,896 Previous Clinical Trials
8,089,804 Total Patients Enrolled

Media Library

AGEN1884 (PD-1 Inhibitor/CTLA-4 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03894215 — Phase 2
Cervical Cancer Research Study Groups: AGEN2034 + Placebo, AGEN2034 + AGEN1884
Cervical Cancer Clinical Trial 2023: AGEN1884 Highlights & Side Effects. Trial Name: NCT03894215 — Phase 2
AGEN1884 (PD-1 Inhibitor/CTLA-4 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03894215 — Phase 2
~33 spots leftby Dec 2025
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