Trial · NCT07243470
Combination of Tarlatamab and Temozolomide in Patients With Central Nervous System Tumors
NCT07243470, Phase 1, Phase 2, Recruiting, Centre Leon Berard
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Combination of Tarlatamab and Temozolomide in Patients With Central Nervous System Tumors. Trials, record NCT07243470. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07243470
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination of Tarlatamab and Temozolomide in Patients With Central Nervous System Tumors
- NCT number
- NCT07243470
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 70 participants, estimated
- Lead sponsor
- Centre Leon Berard
- Conditions
- Glioma, CNS Tumor, Adult, CNS Tumor, Childhood
- Interventions
- Tarlatamab, Temozolomide (TMZ)
- First posted
- 2025-11-24
- Last updated
- 2026-09-14
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase I : Dose limiting toxicities (DLT) assessed as related at least to tarlatamab, occurring during the first 2 cycles of treatment | From Cycle 1 Day 1 to week 8 | Dose limiting toxicities (DLT) defined as the following adverse event (AE) graded according to NCI CTCAE V5.0 or specific grading system for ICANS and CRS, assessed as related at least to tarlatamab, occurring during the first 2 cycles of treatment (i.e. DLT period is 8 weeks for DL1 or 12 weeks if DL-1 is investigated) : - Any Grade 4 non-laboratory toxicity (including CRS). * Any Grade 3 non-laboratory toxicity (including CRS) lasting \>7 days despite optimal supportive care and with the following exceptions: Grade 3 fatigue, Grade ≥ 3 Diarrhea/Vomiting/Nausea adequately managed with supportive care measures within 14 days. * Grade ≥ 3 ICANS. * Any Grade 3 or Grade 4 laboratory value if medical intervention is required or the abnormality persists for \>1 week. * Febrile neutropenia Grade ≥ 3 * Grade 4 anemia * Any Grade 5 toxicity (i.e., toxic death) * Any other significant toxicity deemed by the investigator and/or member of the steering meeting to be dose limiting. |
| Primary | Phase II : To assess the clinical activity of the proposed therapeutic strategy in 3 parallel and independent cohorts of CNS tumors (IDH-mutant glioma, other glioma and other CNS tumors). | 12 weeks from the date of first study drug administration (Cycle 1 Day 1) | Objective response rate at 12 weeks (ORR-12W) according to immunotherapy Response Assessment for Neuro-Oncology (iRANO) criteria |
| Secondary | Evaluation of the Duration of Response (DoR) | From the time of first documented response (Complete Response or Partial Response as per iRANO) until the first documented disease progression or death due to underlying cancer, or censored at the date of the last available tumor assessment | |
| Secondary | Evaluation of the time to objective response (ToR) | From Cycle 1 Day 1 to first documented objective response | Time to objective Response is defined as time to first documented objective response (Complete Response or Partial Response as per iRANO) following Cycle 1 Day 1 |
| Secondary | Evaluation of Disease Control Rate (DCR) | From enrollment to the end of treatment at 12 months | Disease Control Rate (DCR) will be calculated as the percentage of patients who achieve complete response, partial response, or at least six months of stable disease. |
| Secondary | Evaluation of Progression-Free Survival (PFS) | From Cycle 1 Day 1 to the date of the first disease progression or death | Progression-Free Survival will be measured from C1D1 to the date of the first disease progression or death and will be estimated using the Kaplan-Meier method. |
| Secondary | Evaluation of Overall Survival (OS) | From Cycle 1 Day 1 to the date of death from any cause | Overall survival will be estimated using the Kaplan-Meier method. |
| Secondary | To collect nature, incidence and severity of Adverse Events graded using Common Terminology Criteria for Adverse Events (CTCAE) V5.0 or specific grading system for ICANS and CRS [safety and tolerability] | From enrollment to the end of treatment at 12 months | To characterize the safety and tolerability profile of the proposed therapeutic strategy |
| Other | To identify biomarkers predictive of tumor response including DLL3 expression during treatment using descriptive statistics and appropriate multivariate models | From enrollment to the end of treatment at 12 months | Exploratory analyses in tumor will be performed in an effort to understand the association of DLL3 expression with treatment response. Exploratory data will be summarized using descriptive statistics (e.g. N, medians, inter-quartile range, and mean, standard deviation, minimum and maximum for continuous variables and frequency counts and percentages for categorical variables). The relationship between biomarker and efficacy variables will be assessed using appropriate multivariate models. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers44
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07243470
GET https://conductscience.org/api/trials/v1/NCT07243470/papers?page=2