Status and phase
Conditions
Treatments
About
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).
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria:
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
Patients must have exhausted or declined all standard therapies deemed to have significant clinical benefit
Patients may have only 0 or 1 intervening lines of therapy from the prior PD-(L)1 blocking therapy
Patient must be willing and able to provide blood samples (12 green-top tubes, roughly 100mL) at the four time points indicated in the Study Calendar.
Age ≥ 18 years.
ECOG 0-2. The exception will be patients carrying long term disability (such as cerebral palsy) where the disability is not acute nor progressive, and unlikely to significantly affect their response to therapy. This must be documented in screening clinic visit note by investigator.
Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 3 months following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
Ability to understand and the willingness to sign a written informed consent.
Adequate organ and marrow function
Exclusion Criteria
Primary purpose
Allocation
Interventional model
Masking
24 participants in 1 patient group
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Central trial contact
Aleksandra Wawrzyniak
Data sourced from clinicaltrials.gov
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