Clinical Trials Logo

Clinical Trial Summary

This is a Phase 1/2, open-label, multi-arm study, of AGEN1884 in combination with AGEN2034 in subjects with advanced solid tumors including cervical cancer.


Clinical Trial Description

This is a Phase 1/2, open-label, multi-arm study, of AGEN1884 in combination with AGEN2034 in subjects with advanced solid tumors including cervical cancer. AGEN2034 is a novel, fully human monoclonal immunoglobulin G4 (IgG4) antibody, designed to block program cell death-1 (PD-1). AGEN1884 is a novel, fully human monoclonal immunoglobulin G1 (IgG1) antibody, designed to block cytotoxic T lymphocyte antigen-4 (CTLA-4).

The study consists of two phases:

- Phase 1: Dose escalation

- Phase 2: Expansion in Select Tumors - CERVICAL

Phase 1: Part A - Dose Escalation:

The study will consist initially of a 3+3 dose escalation that will evaluate different combination dose levels of AGEN1884 and AGEN2034 in subjects with advanced / refractory solid tumors.

Phase 2: Expansion in Select Tumors

To further characterize safety and efficacy, the following expansion cohort will be enrolled:

Part B - recurrent, unresectable, or metastatic cervical cancer In Phase 2, the selected CDL of AGEN2034 and AGEN1884, established in Part A, will be administered for a maximum of 2 years or until confirmed progression, unacceptable toxicity, or any criterion for stopping the study drugs or withdrawal from the trial occurs.

For the Phase 2 portion of the study, an Independent Data Management Committee (IDMC) will be established to evaluate safety and efficacy and an Independent Endpoint Review Committee (IERC) will be established to adjudicate tumor response. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03495882
Study type Interventional
Source Agenus Inc.
Contact Sara Coulter
Phone 781.674.4480
Email sara.coulter@agenusbio.com
Status Recruiting
Phase Phase 1/Phase 2
Start date December 18, 2017
Completion date March 4, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT03367871 - Combination Pembrolizumab, Chemotherapy and Bevacizumab in Patients With Cervical Cancer Phase 2
Recruiting NCT03668639 - Safety and Antiemetic Efficacy of Akynzeo Plus Dexamethasone During Radiotherapy and Concomitant Weekly Cisplatin Phase 2/Phase 3
Recruiting NCT03676959 - A Clinical Study of PD-L1 Antibody ZKAB001(Drug Code) in Recurrent or Metastatic Cervical Cancer Phase 1
Withdrawn NCT03007771 - Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia Phase 1
Completed NCT03384511 - The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies. Phase 4
Completed NCT00543543 - Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001) Phase 3
Active, not recruiting NCT02420665 - Use of High-Resolution Microendoscopy (HRME) in Patients With Cervical Dysplasia Early Phase 1
Not yet recruiting NCT03386695 - Acceptability and Validity of Self Sampling for High Risk HPV Detection Among Women in Maharashtra N/A
Recruiting NCT02993900 - Image-Guided Gynecologic Brachytherapy Phase 2
Recruiting NCT03155529 - Three-dimensional Study on the Structural Destruction of Pelvic Anatomy in Cervical Cancer N/A
Completed NCT02945111 - Watching Live VIA/VILI Examinations on a Digital Screen May Reduce Patients' Anxiety N/A
Not yet recruiting NCT02875990 - Characterization of Immunosuppressive Signing of Cervical Cancer N/A
Recruiting NCT02576262 - HPV Integration Testing for Human Papillomavirus-Positive Women N/A
Recruiting NCT02503917 - Gynaecologic Organ Segmentation and Motion Tracking Using Ultrasound N/A
Recruiting NCT02705612 - Phase II Clinical Trial of Concurrent Chemoradiotherapy Combined Nimotuzumab for Stage IIB-IVA Cervical Cancer Phase 2
Completed NCT02714127 - Standard Operating Procedures for Cervical (Pre)Cancer Biomarker Detection in First-void Urine (BM-SOP Study) N/A
Completed NCT02546752 - Use of a Patient Education/Messaging Platform to Increase Uptake and Series Completion of the HPV Vaccine Phase 0
Completed NCT02865837 - Effect of Bladder Distension on Dosimetry in Brachytherapy of Cervical Cancer N/A
Active, not recruiting NCT02058550 - Phone or Email Reminder in Increasing Vaginal Dilator Use in Patients With Gynecologic Cancers Undergoing Brachytherapy Phase 1
Completed NCT02096783 - Scripted Sexual Health Informational Intervention in Improving Sexual Function in Patients With Gynecologic Cancer N/A