XmAb23104 (PD1 X ICOS) and XmAb22841 (CTLA-4 X LAG3) in Treating Melanoma Prior Immune Checkpoint… (NCT05695898) | Clinical Trial Compass
TerminatedPhase 1
XmAb23104 (PD1 X ICOS) and XmAb22841 (CTLA-4 X LAG3) in Treating Melanoma Prior Immune Checkpoint Inhibitor Therapy
Stopped: Sponsor decision
United States6 participantsStarted 2023-02-28
Plain-language summary
This is a first-in-human, multi-center, multi-cohort, open-label, phase Ib/II study of XmAb22841 (CTLA-4 X LAG3) administered in combination with XmAb23104 (PD1 X ICOS) in participants with a histologically or cytologically confirmed diagnosis of an advanced/metastatic melanoma. XmAb22841 (CTLA-4 X LAG3) is a bi-specific antibody targeting two different T cell membrane proteins responsible for regulation of T cell activity. It offers potential immunologic and safety advantages over existing therapies. XmAb22841 (CTLA-4 X LAG3) is being evaluated in this clinical study designed to assess the safety, tolerability, PK, and PD of escalating doses of XmAb22841 (CTLA-4 X LAG3) administered in combination with XmAb23104 (PD1 X ICOS)
The study will be conducted through the University of California Melanoma Consortium (UCMC).
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
. Participants must have a histologically or cytologically confirmed advanced/metastatic melanoma by pathology report. Participants with cutaneous, mucosal, acral and unknown primaries will be allowed.
. Participants must have progressed on either single agent programmed cell death protein 1 (PD1) or combination PD1/ cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibition therapy.
. Participants are allowed to have up to 4 prior lines of therapy in the metastatic setting.
. For Dose Escalation Phase, central nervous system (CNS) disease is not required, but it is permitted, provided the following three CNS criteria are met:
Exclusion criteria
. For Dose Expansion Phase:
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.
What they're measuring
1
Number of Treatment- Emergent Adverse Events (Part 1)
Timeframe: Up to 24 months
2
Number of Treatment- Emergent, Immune-Related, Adverse Events (Part 1)
Timeframe: Up to 24 months
3
Number of Participants with Dose Limiting Toxicities (DLT) (Part 1)
. Participants must have measurable disease according to RECIST 1.1 with the following modification for brain lesions (if brain lesions are present):
. Age \>=18 years.
. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Karnofsky \>60%).
. Demonstrate adequate organ function as defined below obtained within 14 days prior to the start of study treatment:
0. For HIV-infected participants, participants must have well controlled HIV on anti-retroviral therapy (ART), defined as:
1. The effects of XmAb23104 and XmAb22841 on the developing human fetus and nursing infant are unknown. Additionally, it is not known if XmAb23104 and XmAb22841 have transient adverse effects on the composition of sperm. Therefore, participants who enroll in this trial must agree to follow the below contraception requirements.
. has reached a postmenopausal state (\>= 12 continuous months of amenorrhea with no identified cause other than menopause)