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Anti-viral agent

Participants with Relapsed Refractory Solid Tumors for Solid Tumors

Phase 1 & 2
Waitlist Available
Led By Thomas Marron, MD
Research Sponsored by Thomas Marron
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Patients must have a pathologically confirmed diagnosis of a solid malignancy
* Patients must have progressed (clinically or radiographically) on or following prior therapy with a PD-1 or PD-L1 targeted antibody
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of study at 3 years
Awards & highlights

Summary

Single arm, set dose clinical trial of Lamivudine for Relapsed Refractory Solid Tumors. Accrual 6-24 patients, within 2 years, study completion within 3 years at Mount Sinai Health System. Primary Objective: For Phase 1b to determine the safety and tolerability of Lamivudine with continued PD-(L)1 blockade for patients with relapsed/refractory metastatic solid tumors that have progressed on standard PD-(L)1 blockade. For Phase 2, to determine the effect of adding lamivudine to PD-(L)1 blocking agents in patients with relapsed/refractory solid tumors that have progressed on prior PD-(L)1 agents Secondary Objectives (Phase 1b and 2) Assess 1) Safety and Tolerability, 2) Best overall response rate (BORR), 3) Progression-free survival (PFS), 4) Overall survival (OS) and 5) Duration of response following addition of lamivudine to standard PD-(L)1 blocking agents, 6) Disease control rate (DCR).

Who is the study for?
This trial is for patients with relapsed/refractory metastatic solid tumors that didn't respond to standard PD-(L)1 blockade treatments. It's a small study, aiming to enroll 6-24 participants over two years at Mount Sinai Health System.
What is being tested?
The trial is testing the safety and effectiveness of Lamivudine when added to ongoing PD-L1 blocker therapy in patients whose solid tumors have not improved with previous treatments. The goal is to see if this combination can better control tumor growth.
What are the potential side effects?
Possible side effects include those commonly associated with Lamivudine and PD-L1 blockers, such as fatigue, nausea, immune-related reactions like inflammation in organs or skin rashes, and an increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of study at 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study at 3 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
Dose limiting toxicity (DLTs) per CTCAE Version 5.0
Secondary outcome measures
Best overall response rate (BORR).
DLT of combined treatment of lamivudine and PD-(L)1 targeted therapy.
Disease control rate (DCR)
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Participants with Relapsed Refractory Solid TumorsExperimental Treatment2 Interventions
Participants with Solid Tumors which are typically treated with cancer immunotherapy (PD-1 or PD-L1 blocking antibodies) and their cancer has progressed on immunotherapy will be candidates for the trial. This is a single-arm trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lamivudine
2006
Completed Phase 4
~8120

Find a Location

Who is running the clinical trial?

Thomas MarronLead Sponsor
1 Previous Clinical Trials
21 Total Patients Enrolled
Thomas Marron, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
3 Previous Clinical Trials
67 Total Patients Enrolled
~16 spots leftby Jul 2027