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Immunotherapy

OBX-115 for Skin Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Obsidian Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant experienced documented radiographic disease progression after systemic therapy containing a programmed cell death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) blocking antibody. If the tumor is BRAF V600 mutation-positive, the participant should also have received a BRAF inhibitor with or without a MEK inhibitor.

After tumor tissue procurement, the participant will have at least one remaining measurable lesion, as defined by RECIST v1.1.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial tests a new treatment for advanced skin cancer to see how safe and effective it is in adults.

Who is the study for?

Adults with advanced melanoma resistant to immune checkpoint inhibitors can join. They must have had disease progression after specific systemic therapies, at least one resectable lesion for OBX-115 generation, and be in good health otherwise. Participants need proper organ function, an ECOG status of 0 or 1, and agree to use contraception.Check my eligibility

What is being tested?

The trial is testing the safety and effectiveness of a new treatment called OBX-115 on adults with advanced melanoma that hasn't responded to previous treatments including PD-1/PD-L1 blockers and possibly BRAF/MEK inhibitors.See study design

What are the potential side effects?

While not explicitly listed here, side effects are likely related to the immune system's response to OBX-115 and may include typical reactions such as fatigue, flu-like symptoms, allergic reactions or skin changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer progressed after treatment with PD-1/PD-L1 inhibitors and, if applicable, BRAF/MEK inhibitors.

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I have at least one tumor that can be measured after a biopsy.

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I can care for myself and doctors expect me to live more than 6 months.

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My blood tests meet the study's requirements for white blood cells and platelets.

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I have been diagnosed with advanced or metastatic melanoma.

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I am 18 years old or older.

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I have recovered from side effects of previous cancer treatments.

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I have at least one tumor that can be surgically removed for treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence and nature of dose-limiting toxicities (DLTs)

The proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.1

Secondary outcome measures

Incidence of AEs

The proportion of participants who have a confirmed CR or PR per RECIST v1.1

Trial Design

1Treatment groups

Experimental Treatment

Group I: Participants with advanced solid tumorsExperimental Treatment1 Intervention

Participants will receive conditioning therapy prior to administration of OBX-115 regimen.

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Obsidian Therapeutics, Inc.Lead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings for participation in this research?

"According to clinicaltrials.gov, this particular study is not actively recruiting any more members, as the post date was 9/22/2023 and it hasn't been updated since then. Nevertheless, there are 808 other trials enrolling patients at present."

Answered by AI

Who else is applying?

What site did they apply to?

James Graham Brown Cancer Center

What portion of applicants met pre-screening criteria?

Did not meet criteria

Why did patients apply to this trial?

My husband has metastatic melanoma and the immunotherapy has not worked. He's only 54 and is in otherwise good health. The next step his doctor wants to try is Interluken 2 and my husband has opted to additionally have stereostatic radiation of the liver, lung tumor and kidney adjacent tumor.

PatientReceived no prior treatments

Recent research and studies

clinicaltrials.govStudy

Safety and Efficacy of OBX-115 in Advanced Solid Tumors

2023. "Safety and Efficacy of OBX-115 in Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06060613.

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