120 Participants NeededMy employer runs this trial

Denikitug Combinations for Esophageal Cancer

Recruiting at 14 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
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 tests a new drug, Denikitug (GS-1811), for individuals with certain types of esophageal cancer that cannot be surgically removed or has metastasized. Researchers aim to evaluate the effectiveness of Denikitug alone or in combination with other treatments, such as nivolumab (which aids the immune system in fighting cancer) and ramucirumab with paclitaxel (a chemotherapy combination). Individuals with HER2-negative gastroesophageal or esophageal cancer who have experienced disease progression after initial treatments may qualify for participation. The goal is to identify the best approach to improve response rates in these cancers. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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

The trial information does not specify if you need to stop taking your current medications. However, it mentions that you should not have unresolved side effects from recent chemotherapy or other treatments before enrolling. It's best to discuss your specific medications with the trial team.

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

Research has shown that Denikitug (GS-1811) is generally safe. Studies have found that its side effects align with its action on certain immune cells, so some reactions can be expected.

When combined with nivolumab, an FDA-approved treatment for other uses, studies indicate that Denikitug is usually well-tolerated. However, a small number of patients in related treatments experienced serious side effects, such as pneumonia and difficulty swallowing.

Denikitug is also undergoing testing with ramucirumab and paclitaxel. These standard treatments are generally well-tolerated, though some patients have experienced severe bleeding.

These findings suggest that while Denikitug and its combinations can cause side effects, they are mostly expected and manageable based on previous research. Participants should discuss any concerns with their healthcare provider.12345

Why are researchers excited about this trial's treatments?

Denikitug (GS-1811) is unique because it targets esophageal cancer in a novel way by combining with other treatments like nivolumab, ramucirumab, and paclitaxel. While standard treatments often rely on chemotherapy and radiation, Denikitug works differently by potentially enhancing the immune response and targeting specific cancer pathways. Researchers are excited about Denikitug because its combination approach might offer a more tailored attack against cancer cells, potentially leading to better outcomes and fewer side effects compared to traditional therapies.

What evidence suggests that this trial's treatments could be effective for esophageal cancer?

This trial will evaluate different combinations of Denikitug for esophageal cancer. Studies have shown that combining Denikitug with nivolumab can significantly extend the lives of patients with this condition. Specifically, patients who received this combination had better survival rates than those who only underwent chemotherapy. In this trial, some participants will receive Denikitug with nivolumab. Another combination under study is Denikitug with ramucirumab plus paclitaxel, which has proven effective as a second treatment option for advanced esophageal cancer, extending patient survival. Early research suggests that Denikitug can enhance these treatments, possibly reducing tumor size more effectively. These findings offer hope for improved treatment outcomes for patients with advanced esophageal cancer.23467

Who Is on the Research Team?

GS

Gilead Study Director

Principal Investigator

Gilead Sciences

Are You a Good Fit for This Trial?

This trial is for adults with HER2-negative, advanced or metastatic stomach, gastroesophageal junction (GEJ), or esophageal adenocarcinoma. Participants must have already tried certain standard treatments and be in good physical condition with working major organs. Both men and women of childbearing age must use contraception.

Inclusion Criteria

I have advanced or metastatic gastric, GEJ, or esophageal adenocarcinoma confirmed by biopsy.
My cancer has tested negative for HER2.
My advanced stomach or esophageal cancer got worse after first-line treatment.
See 3 more

Exclusion Criteria

I have received Lonsurf or paclitaxel as my first treatment for advanced gastroesophageal cancer.
I have received treatment that targets VEGF or VEGFR pathways.
I have had noninfectious pneumonitis or interstitial lung disease needing steroids.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Denikitug as monotherapy or in combination with Nivolumab or Chemotherapy

Up to 4 years
Regular visits for IV infusions

Safety Run-in

Participants receive DEN in combination with ramucirumab and paclitaxel to assess safety

Variable, until safety is confirmed

Expansion

If DEN dose is deemed safe, participants receive DEN at recommended dose in combination with RAM and PAC

Continuation from Safety Run-in

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Denikitug (GS-1811)
  • Nivolumab
  • Paclitaxel
  • Ramucirumab

Trial Overview

The study tests Denikitug alone or combined with nivolumab, ramucirumab, and paclitaxel to see how well these treatments work against advanced gastric, GEJ, or esophageal cancers. Patients are assigned to different groups based on the treatment combinations.

How Is the Trial Designed?

5

Treatment groups

Experimental Treatment

Group I: Part 2: Arm D: Safety Run-in (SRI) CohortExperimental Treatment3 Interventions
Group II: Part 2: Arm D: Expansion CohortExperimental Treatment3 Interventions
Group III: Part 1: Arm C: DEN (Dose B)Experimental Treatment1 Intervention
Group IV: Part 1: Arm B: DEN (Dose B) and NIVOExperimental Treatment2 Interventions
Group V: Part 1: Arm A: DEN (Dose A) and NIVOExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Gilead Sciences

Lead Sponsor

Trials
1,150
Recruited
878,000+
Daniel O'Day profile image

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger profile image

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

Citations

NCT07546812 | Study of Denikitug (GS-1811) Given Alone ...

The goal of this clinical study is to learn more about the study drug, Denikitug (DEN, GS-1811), to evaluate the efficacy and safety of Denikitug Monotherapy

Clinical trial results for advanced esophageal squamous ...

More people given OPDIVO + chemotherapy were alive at 1 year compared to chemotherapy alone. Tumors disappeared completely (complete response) 14% saw tumors ...

Denikitug - Drug Targets, Indications, Patents

Esophageal Adenocarcinomas. Gilead drug is the only one that has demonstrated an overall survival benefit.

Study of Denikitug (GS-1811) Given Alone or With ...

The goal of this clinical study is to learn more about the study drug, Denikitug (DEN, GS-1811), to evaluate the efficacy and safety of Denikitug Monotherapy

Real-world clinical outcomes of nivolumab and taxane ... - PMC

In real-world practice, nivolumab was safer and more effective than taxane in patients with ESCC with diverse clinical profiles who did not meet ...

denikitug (GS-1811) / Gilead

Esophageal Adenocarcinomas. DEN demonstrates a manageable safety profile and TRAEs were consistent with a Treg depleting mechanism of action." Esophageal ...

Clinical trial results for advanced gastroesophageal cancer

OPDIVO is safe and effective in children younger than 12 years of age with melanoma. It is not known if OPDIVO is safe and effective in children for the ...