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New treatment option for Melanoma
Official title Radiation Combined With BIspecific T-Cell Engager in DLL3 Expressing Tumors
ClinicalTrials.gov ID: NCT06814496
What this study is testing
What is Tarlatamab?
Tarlatamab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for melanoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- Subject has provided informed consent/assent prior to initiation of any study specific activities/procedures.
- people ≥ 18 years of age at the time of signing the informed consent.
- Histologically or cytologically confirmed relapsed/refractory:
- SCLC
- Other tumors of small cell histology
You likely can't join if
- Re-irradiation, unless it is SRS/hfSRT after whole-brain radiation therapy (WBRT) or PCI or WBRT after SRS/hfSRT; re-irradiation of same lesion...
- people are excluded from the study if any of the following criteria apply: a. No lesion(s)/site(s) amenable to radiation therapy (only eligible for...
- Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
- people who experienced recurrent pneumonitis (grade 2 or higher) or severe, life-threatening immune-mediated adverse events or infusion-related...
- Unresolved toxicity from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version...
- Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association \> class II) within 12 months of first dose of...
See the full eligibility criteria
Who can join
- Subject has provided informed consent/assent prior to initiation of any study specific activities/procedures.
- people ≥ 18 years of age at the time of signing the informed consent.
- Histologically or cytologically confirmed relapsed/refractory:
- SCLC
- Other tumors of small cell histology
- High grade / poorly differentiated neuroendocrine histology tumor histologies with high prevalence of DLL3 (≥50% prevalence of ≥1% positivity), including but not limited to: melanoma, medullary thyroid cancer...
- DLL3+ (≥1% by IHC) Note: If patients are DLL3 negative per IHC but have a DLL3 prevalant tumor type, they will be allowed to enroll on the study.
- people who progressed or recurred after at least one line of therapy and are considered treatment refractory per standard of care.
- people willing to provide archived tumor tissue samples (formalin fixed, paraffin embedded [FFPE] sample). If no archived tumor tissue is available, we request to undergo pretreatment tumor biopsy. people who do not...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Minimum life expectancy of 12 weeks.
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen.
- Measurable lesions as defined per RECIST 1.1 within 28 days prior to the first dose of tarlatamab.
- Eligible for external beam radiation therapy to a previously unirradiated, measurable lesion as per standard of care. a. For the concurrent / sequential cohort of extracranial RT sites: i. A minimum of 10 people with...
- Definitive therapy was completed at least 2 weeks prior to the first dose of tarlatamab.
- There is no evidence of radiographic central nervous system (CNS) progression following therapy and by the time of study screening.
- Patients manifesting progression in lesions previously treated with stereotactic radiosurgery may still be eligible if pseudoprogression can be demonstrated by appropriate means.
- Any CNS disease is asymptomatic for at least 7 days (unless symptoms are deemed irreversible by the investigator), the patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the...
- Prior PCI or whole brain radiation therapy per standard of care with new and/or recurrent brain metastases to be treated with SRS or hfSRT
- Prior course(s) of SRS or hfSRT or other localized therapy with new lesion(s) to be treated with whole brain radiation therapy iii. Whole brain re-irradiation will be ineligible iv. Re-irradiation with SRS or hfSRT of...
What rules you out
- Re-irradiation, unless it is SRS/hfSRT after whole-brain radiation therapy (WBRT) or PCI or WBRT after SRS/hfSRT; re-irradiation of same lesion, unless verified with the Principal Investigator; patients with lesions not...
- people are excluded from the study if any of the following criteria apply: a. No lesion(s)/site(s) amenable to radiation therapy (only eligible for tarlatamab monotherapy if open) b. Planned re-irradiation of a...
- Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
- people who experienced recurrent pneumonitis (grade 2 or higher) or severe, life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on...
- Unresolved toxicity from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1, or to levels dictated in the eligibility criteria with the...
- Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association \> class II) within 12 months of first dose of tarlatamab.
- History of arterial thrombosis (i.e., stroke or transient ischemic attack) within 12 months of first dose of tarlatamab.
- Subject with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of tarlatamab. NOTE: Simple urinary tract...
- History of hypophysitis or pituitary dysfunction.
- Exclusion of hepatitis infection based on the following results and/or criteria: a. Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B). b. Negative HBsAg and...
- Major surgery requiring hospitalization for more than 3 days within 28 days of first dose of tarlatamab.
- Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study.
- Human immunodeficiency virus (HIV) infection. a. people with HIV infection on antiviral therapy and undetectable viral load are permitted with a requirement for regular monitoring for reactivation for the duration of...
- Subject received prior therapy with tarlatamab.
- Prior anti-cancer therapy within 30 days prior to first dose of tarlatamab. Exceptions: a. people who received conventional chemotherapy are eligible if at least 14 days have elapsed and if all treatment-related...
- Has a diagnosis of immunodeficiency (i.e., positive/non-negative test for human immunodeficiency virus) or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the...
- The following vaccines (live and live-attenuated vaccines) are excluded during the following study periods:
- Screening and during study treatment: Live and live-attenuated vaccines are prohibited within 28 days prior to the first dose of tarlatamab and for the duration of the study.
- Live viral non-replicating vaccine (i.e., Jynneos) for Monkeypox infection is allowed during the study (except during cycle 1) in accordance with local standard of care (SOC) and institutional guidelines.
- End of study treatment: Live and live-attenuated vaccines can be used when at least 60 days (5 x half-life of tarlatamab) have passed after the last dose of tarlatamab. Other Exclusions 1\. Female people of childbearing...
- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal)
- Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, and implantable)
- Intrauterine device
- Intrauterine hormonal-releasing system
- Bilateral tubal ligation/occlusion
- Vasectomized partner (provided that partner is the sole sexual partner of the female subject of childbearing potential and that the vasectomized partner has received medical assessment of the surgical success)
- Sexual abstinence (defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments; the reliability of sexual abstinence must be evaluated in relation to the...
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.