Thiopurine Enhanced Mutations for PD-1/Ligand-1 Efficacy

Sponsor
Kristoffer Rohrberg
Study ID
NCT05276284
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Metastatic Cancer
  • Solid Tumor, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The TEMPLE study is a single-center prospective phase Ib and II trial to determine the safety, tolerability and efficacy of Atezolizumab given in combination with thiopurine therapy (6-mercaptopurine and 6-thioguanine) in patients with advanced and/or metastatic solid tumors with an intermediate tumor mutational burden. Maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) will be determined in a single armed, open label phase Ib trial with a fixed dose of Atezolizumab in combination with thiopurine therapy with a dose-limiting toxicity (DLT) period of 4 weeks. A total of 27-39 patients will be enrolled in the TEMPLE study. Phase Ib will enroll 3-18 patients depending on the number of DLTs and need for dose de-escalation. Data from patients treated in the phase Ib study at RP2D will be included when assessing endpoints in the phase II part of the study. Phase II will enroll a total of 27 patients (including 3-6 patients treated at RP2D in the phase I part of the trial) in a Simon's 2 stage design (13 in stage 1 and 14 in stage 2).

Key Dates

Start date
Sep 1, 2022
Status verified
Jan 2026
Primary completion
Dec 31, 2024
Completion
Sep 1, 2025

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TEMPLE
    Study drugs: Atezolizumab, 6-mercaptopurine and 6-thioguanine

Primary Outcome Measure

Adverse events [ Time Frame: 3-6 months ]

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