OncoMatch/Clinical Trials/NCT06814496
Radiation Combined With BIspecific T-Cell Engager in DLL3 Expressing Tumors
Is NCT06814496 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies Tarlatamab for melanoma.
Treatment: Tarlatamab — Phase I study to examine safety of the addition of concurrent tarlatamab with standard palliative and consolidative RT regimens , with a main cohort of N=20-24 patients with extracranial anatomic radiation sites. I) After lead in of 10 patients demonstrating safety of treatment, allow for expansion to cranial sites of disease (N=6-10) with continued enrollment in main cohort II) If toxicity criteria is not met in concurrent RT tarlatamab cohort, we will continue with sequential RT, either A) delivered within 7 days prior to cycle 1 day 1, or B) delivered during cycle 1 -2 but with pre- and post-RT washout of 7 days with no drug during RT, to examine safety in a temporally spaced setting. III) If sequential tarlatamab and radiation is not deemed safe, we would allow for continued enrollment to assess efficacy of drug sans radiation treatment, enriching for tumors not of small cell lung cancer histology and allowing for patients without sites amenable to RT. A nested phase II study will attempt to assess for ORR and safety of study intervention amongst tumors not of small cell lung cancer histology.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Cancer type
Melanoma
Thyroid Gland Carcinoma
Urothelial Carcinoma
Testicular Germ Cell Tumor
Glioblastoma
Cervical Cancer
Neuroendocrine Tumor
Non-Small Cell Lung Carcinoma
Tumor Agnostic
Disease stage
Grade: high grade / poorly differentiated
relapsed/refractory; measurable lesions as defined per RECIST 1.1
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: systemic therapy
Subjects who progressed or recurred after at least one line of therapy and are considered treatment refractory per standard of care
Cannot have received: tarlatamab (tarlatamab)
Subject received prior therapy with tarlatamab
Lab requirements
Blood counts
ANC ≥ 1.5 x 10^9/L; platelets ≥ 100 x 10^9/L; hemoglobin > 9 g/dL
Kidney function
eGFR > 30 mL/min/1.73 m2
Liver function
AST, ALT, ALP < 3 x ULN (or < 5 x ULN for subjects with liver involvement); total bilirubin < 1.5 x ULN (or < 2 x ULN for subjects with liver metastases)
Cardiac function
Cardiac ejection fraction ≥ 50%, no clinically significant pericardial effusion, no clinically significant ECG findings
Adequate organ function, defined as follows: Hematological function: ANC ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L, hemoglobin > 9 g/dL; Coagulation: PT/INR and PTT/APTT ≤ 1.5 x ULN; Renal: eGFR > 30 mL/min/1.73 m2; Hepatic: AST, ALT, ALP < 3 x ULN (or < 5 x ULN for subjects with liver involvement), total bilirubin < 1.5 x ULN (or < 2 x ULN for subjects with liver metastases); Pulmonary: no clinically significant pleural effusion, baseline O2 sat > 90% on room air; Cardiac: ejection fraction ≥ 50%, no clinically significant pericardial effusion, no clinically significant ECG findings
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Arizona Cancer Center at UMC North/University Medical Center · Tucson, Arizona
- University of Washington Fred Hutchinson Cancer Center · Seattle, Washington
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06814496 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior tarlatamab disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 99 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages