Is NCT07544654 recruiting in Boston, MA?

Yes, NCT07544654 is currently recruiting participants at its Boston, MA location. This extrapulmonary neuroendocrine cancer (epnec) clinical trial is actively enrolling qualified participants.

Is participation in this Boston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Extrapulmonary Neuroendocrine Cancer (epNEC) Clinical Trial in Boston, MA

Q: How do I join the extrapulmonary neuroendocrine cancer (epnec) clinical trial in Boston?

To join this clinical trial in Boston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Extrapulmonary Neuroendocrine Cancer (epNEC) Study in Boston

This study is open to adults with advanced extrapulmonary neuroendocrine cancer. The purpose of this study is to find out if a study medicine called obrixtamig plus standard chemotherapy (carboplatin and etoposide) improves survival when compared to standard chemotherapy (carboplatin and etoposide) alone. Obrixtamig is an antibody-like molecule that may help the immune system fight cancer. Another purpose of the study is to test a medical device being developed to measure levels of the tumour marker delta-like ligand 3 (DLL3). Participants are put into 2 groups randomly, which means by chance. One group (treatment arm) receives obrixtamig and standard chemotherapy followed by obrixtamig alone for up to 3 years. The other group (control arm) receives standard chemotherapy without obrixtamig for about 4 months. All treatments are given as infusions into a vein. During the study, participants in both groups visit the study site regularly. Participants in the treatment arm stay overnight at the study site following the first 2 obrixtamig treatments. The doctors regularly check participants' health and take note of any unwanted effects. At some of the visits, doctors check the size of the tumour(s). The results are compared between the 2 groups to see whether the treatment works.

Sponsor: Boehringer Ingelheim

Who Can Participate

Inclusion Criteria

Patients with poorly differentiated unresectable locally advanced or metastatic extrapulmonary neuroendocrine carcinoma (epNEC) with Ki-67 \>20% or mitotic rate mitotic rate with number of mitoses \>20 per 2 mm2, regardless of primary site (including site of unknown origin)

Patients with tumours with mixed histologies are eligible only if neuroendocrine carcinoma component is predominant and represents more than 70% of the overall tumour tissue

No prior systemic treatment for unresectable locally advanced or metastatic epNEC (except for the completed one cycle of standard platinum + etoposide). Prior peri-operative chemotherapy or -radiation for curative intention is allowed if at least 6 months have elapsed between completion of this therapy and diagnosis of unresectable locally advanced or metastatic disease

Patients who have finished one cycle of standard platinum + etoposide regimen as first-line treatment (Cycle 0: etoposide with carboplatin or cisplatin, administered at a minimum dose of cisplatin 75 mg/m2 or carboplatin area under the curve (AUC) 5 and etoposide 80 mg/m2) prior to randomisation

Patients must comply with criteria for receiving further chemotherapy treatment as first-line standard of care (SoC) treatment within 28 days after the start of the initial chemotherapy (Cycle 0)

Adequate archival Formalin-Fixed Paraffin-Embedded (FFPE) tumour tissue, as specified in the Laboratory Manual, must be available for central laboratory analysis of Delta-like ligand 3 (DLL3) expression status. Tumours must be positive (as defined in the diagnostic study protocol) for DLL3 expression status assessed by investigational VENTANA DLL3 (SP347) RxDx Assay

Eastern Cooperative Oncology Group (ECOG) score of 0 or 1

Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the informed consent form (ICF) Further inclusion criteria apply.

Exclusion Criteria

Presence of leptomeningeal disease and/or carcinomatous meningitis

Patients with diagnosis of Merkel cell carcinoma or medullary thyroid carcinoma

Patients with neuroendocrine prostate cancer

Patients with well-differentiated neuroendocrine tumours of any grade according to the world health organization (WHO) classification, 5th edition

Patients with a history of well differentiated Neuroendocrine tumour (NET) tumour that transformed into poorly differentiated Neuroendocrine carcinoma (NEC)

Previous treatment with obrixtamig or other DLL3-targeting therapies (e.g. T-cell engager (TcEs), cell therapies, antibody-drug conjugates, or radiopharmaceuticals)

Previous treatment with anti-PD-1 or programmed death ligand 1 (PD-L1) therapies during the one cycle of standard platinum + etoposide first-line chemotherapy (Cycle 0)

Toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or grade prior to Cycle 0. Participants with alopecia any grade, CTCAE ≤Grade 2 asthenia/fatigue, amenorrhea/menstrual disorders any grade, CTCAE ≤Grade 2 peripheral neuropathy, and/or CTCAE ≤Grade 2 endocrinopathies controlled by replacement therapy, and toxicities, which are considered irreversible but stable for at least 4 weeks, per Investigator judgement may be eligible Further exclusion criteria apply.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Boston?

Yes, this clinical trial (NCT07544654) has an active research site in Boston, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Extrapulmonary Neuroendocrine Cancer (epNEC) Treatment Options in Boston, MA

If you're searching for extrapulmonary neuroendocrine cancer (epnec) treatment options in Boston, MA, this clinical trial (NCT07544654) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Boston research site is actively enrolling participants for this phase 3 clinical trial. You'll receive care from experienced extrapulmonary neuroendocrine cancer (epnec) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all extrapulmonary neuroendocrine cancer (epnec) clinical trials near you to find additional studies recruiting in your area.

Extrapulmonary Neuroendocrine Cancer (epNEC) Clinical Trial in Boston, MA

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