A Study of Zalifrelimab and Balstilimab for Treatment of Participants With Metastatic or Locally … (NCT03495882) | Clinical Trial Compass
CompletedPhase 1/2
A Study of Zalifrelimab and Balstilimab for Treatment of Participants With Metastatic or Locally Advanced Solid Tumors, and Expansion Into Select Solid Tumors (Cervical)
United States, Australia, Brazil175 participantsStarted 2017-12-18
Plain-language summary
This is a Phase 1/2, open-label study of zalifrelimab (AGEN1884) in combination with balstilimab (AGEN2034) in participants with locally advanced, recurrent and/or metastatic solid tumors including cervical cancer. Balstilimab is a novel, fully human monoclonal immunoglobulin G4 antibody, designed to block program cell death-1 (PD-1). Zalifrelimab is a novel, fully human monoclonal immunoglobulin G1 antibody, designed to block cytotoxic T-lymphocyte antigen-4 (CTLA-4).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Voluntarily agree to participate by giving written informed consent (participation in pharmacogenomics testing is optional).
. Be ≥18 years of age.
. Diagnosis:
. Phase 1: Male or female having a histologically or cytologically confirmed diagnosis of a locally advanced, recurrent, and/or metastatic solid tumor for which no standard therapy is available or standard therapy has failed.
. Phase 2:
. Measurable Disease:
. Phase 1: Have objective evidence of disease; the presence of measurable disease is not required.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Phase 2: Have measurable disease on imaging based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Note: Participants must have at least one "target lesion" to be used to assess response, as defined by RECIST version 1.1. Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented, or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy. Note: Measurable disease by RECIST 1.1 must be confirmed by independent central radiologic review prior to first dose. Participants without centrally confirmed measurable disease at baseline will not be eligible for this trial.
Exclusion criteria
. Is currently participating and receiving trial therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
. Has an inadequate washout period prior to first dose of study drug defined as:
. Received systemic cytotoxic chemotherapy or biological therapy within 3 weeks before first dose,
. Received radiation therapy within 3 weeks before first dose, or
. Had major surgery within 4 weeks before first dose.
. Has received prior therapy with:
. Any antibody/drug targeting T-cell co-regulatory proteins (immune checkpoints) such as anti-PD-1, anti-ligand 1 of programmed cell death protein 1, or anti-CTLA-4 antibodies
. For Phase 2: \>1 systemic treatment regimen for the locally advanced recurrent, and/or metastatic cervical cancer for which the participant is considered for the study. Participants who received a systemic regimen immediately after progressing within 6 months of completing chemotherapy concurrent with primary radiation or adjuvant chemotherapy after radiation will only be considered as having 1 prior systemic regimen for the purpose of this criterion. Note: In Phase 1, prior treatment with a CTLA-4 antibody is permissible for subjects with metastatic melanoma.