390 Participants NeededMy employer runs this trial

Obrixtamig + Chemotherapy for Carcinoid Tumor

Recruiting at 180 trial locations
BI
Overseen ByBoehringer Ingelheim
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Boehringer Ingelheim
Must be taking: Platinum, Etoposide
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a new treatment, obrixtamig, combined with standard chemotherapy, can extend the lives of people with advanced extrapulmonary neuroendocrine cancer. Obrixtamig is a unique molecule that may enhance the immune system's ability to fight cancer. Participants will be randomly assigned to two groups: one receiving obrixtamig with chemotherapy (carboplatin and etoposide) and the other receiving only chemotherapy. The study also tests a device that measures a tumor marker called DLL3. This trial may suit those with advanced neuroendocrine cancer who have not undergone certain previous treatments. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking cancer treatment advancements.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss your specific situation with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found that the combination of obrixtamig and chemotherapy was generally well-tolerated by patients, with no unexpected harmful effects reported. Patients did not experience overlapping side effects, suggesting the treatment may be safe. Other research has also shown that obrixtamig does not cause unexpected harmful effects when combined with other cancer drugs.

The chemotherapy drugs used in this trial, carboplatin and etoposide, are well-known for their predictable side effects. Overall, the safety data so far indicate that the combination of obrixtamig and chemotherapy is manageable for patients, with expected and controllable side effects.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about Obrixtamig for carcinoid tumors because it introduces a novel approach by combining with traditional chemotherapy agents like carboplatin and etoposide. Unlike current treatments that primarily focus on slowing tumor growth, Obrixtamig is designed to enhance the immune system's ability to target and destroy cancer cells. This new mechanism of action offers the potential for improved treatment outcomes, making it a promising addition to the existing standard of care.

What evidence suggests that this trial's treatments could be effective for advanced extrapulmonary neuroendocrine cancer?

This trial will compare the effectiveness of adding obrixtamig to the usual chemotherapy drugs, carboplatin and etoposide, for treating extrapulmonary neuroendocrine cancer. Research has shown that patients who received this combination had a median progression-free survival of 7.6 months, meaning their cancer did not worsen for that time, compared to 5.1 months for those who only had chemotherapy. This suggests that obrixtamig might help delay cancer progression. Additionally, 64% of patients on the combination treatment did not experience cancer progression for at least 6 months. These findings indicate that obrixtamig could enhance the effectiveness of standard chemotherapy.12678

Are You a Good Fit for This Trial?

This trial is for adults with advanced extrapulmonary neuroendocrine cancer whose tumors test positive for DLL3. Participants must have mostly neuroendocrine tumor cells, be in good physical condition (ECOG 0 or 1), and not have had prior treatment for this stage of disease except possibly one cycle of standard chemo.

Inclusion Criteria

I have advanced extrapulmonary neuroendocrine carcinoma with high tumor growth rate.
My tumor is mostly made up of neuroendocrine cancer cells (over 70%).
I am fully active or have only minor physical limitations.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive obrixtamig and standard chemotherapy or standard chemotherapy alone

4 months
Regular visits, with overnight stays for the first 2 obrixtamig treatments

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 38 months

Open-label extension

Participants in the treatment arm may continue obrixtamig alone for up to 3 years

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

  • Carboplatin
  • Etoposide
  • Obrixtamig

Trial Overview

The study compares a new drug called obrixtamig plus standard chemotherapy (carboplatin and etoposide) to standard chemotherapy alone. People are randomly assigned to either group. Obrixtamig may help the immune system fight cancer, and all treatments are given by IV infusion.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Obrixtamig + carboplatin + etoposideExperimental Treatment4 Interventions
Group II: Carboplatin + etoposideActive Control3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials
2,566
Recruited
16,150,000+

Citations

Obrixtamig Plus Carboplatin/Etoposide Shows Early ...

Moreover, the median progression-free survival (PFS) with the combination was 7.6 months (95% CI, 5.8-9.5); the 6-month PFS rate was 64% (95% CI ...

NCT07544654 | DAREON®-NEC-1: A Study in People ...

The purpose of this study is to find out if a study medicine called obrixtamig plus standard chemotherapy (carboplatin and etoposide) improves survival when ...

Comparison of Efficacy and Safety between Carboplatin ...

Statistically, the response rate, progression-free survival time and overall survival time were 42.6%, 5.1 months (95% CI: 3.5–6.3) and 13.6 months (95% CI: 8.9 ...

Treatment outcomes in patients with stage IV large cell ...

Those treated with chemo-immunotherapy had a significantly higher median survival of 10.7 months (95 % CI 9.2–15.9; HR = 0.53, 95 % CI 0.4–0.72, p < 0.001), as ...

Novel therapies targeting delta-like ligand 3 (DLL3) in ...

Prognosis remains extremely poor, with a 5-year overall survival (OS) rate below 5 % [3,4,8]. This highlights the urgent need for novel treatment strategies ...

Abstract LB-A004: DAREON-7: Phase I open-label dose ...

Median progression-free survival was 7.6 (95% CI: 5.8–9.5) months. Conclusion. Obrixtamig plus chemotherapy was tolerable with no unexpected toxicities. The ...

Obrixtamig + Chemotherapy for Carcinoid Tumor

... Carboplatin, Etoposide and Obrixtamig will have tolerable side effects & efficacy for patients with Carcinoid Tumor. Learn more about the study.

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/26636658/

Efficacy and Safety of Carboplatin and Etoposide ...

The median overall survival was 12.7 months, and the median progression-free survival was 7.0 months. The median survival times were 10.8 and ...