Trial-by-gene · TMB-H
Active clinical trials enrolling TMB-high solid tumors
Decision-support aid only — eligibility decisions must be confirmed against the actual trial protocol and the patient's medical record. Trial counts and statuses change daily; this page is for orientation, not adjudication.
TMB-high pan-tumor trials focus on (1) the FDA tumor-agnostic pembrolizumab indication (KEYNOTE-158, second-line solid tumors with TMB ≥10 mut/Mb), (2) TMB-stratified checkpoint inhibitor combination trials in earlier lines and indication-specific settings, and (3) vendor-assay harmonization (FoundationOne CDx, Tempus xT, Caris all report TMB but with different methodologies).
See the MSI-H/dMMR cheat sheet for the adjacent biomarker.
Browse the live listing
Search ClinicalTrials.gov for actively recruiting solid-tumor trials with TMB-high biomarker stratification or eligibility.
Open ClinicalTrials.gov listingSource: ClinicalTrials.gov, US National Library of Medicine. Trial-listing data is in the public domain. Use of ClinicalTrials.gov data must comply with the NLM terms of use.
Representative trial phases and designs
Phase II, tumor-agnostic
Pembrolizumab in TMB-H solid tumors post-standard therapy (KEYNOTE-158 follow-on).
Phase III, NSCLC
TMB-stratified ICI combinations in 1L NSCLC; methodology harmonization.
Phase I/II, novel combinations
TMB-H stratified TIGIT, LAG-3 trials.
Frequently asked questions
- Is TMB-H always defined as ≥10 mut/Mb?
- That's the FDA-approved pembrolizumab tumor-agnostic threshold (FoundationOne CDx). Some assays and indications use different cutoffs (Tempus, Caris). Trial-specific thresholds vary; check the protocol.