What side effects are associated with this type of intervention?

Common treatments for esophageal cancer, such as immunotherapy (e.g., nivolumab, pembrolizumab) and chemotherapy (e.g., paclitaxel, cisplatin), have several known side effects. Immunotherapy can cause skin reactions, endocrine events, pneumonia, diarrhea, and fatigue. Chemotherapy often leads to nausea, vomiting, hair loss, anemia, neutropenia, and increased risk of infection. Specific combinations, like those involving nivolumab and ipilimumab, can result in serious adverse reactions such as febrile neutropenia, acute kidney injury, and pneumonitis. These treatments can also lead to treatment-related discontinuations and, in rare cases, treatment-related deaths.

What prior FDA approvals exist?

The FDA has approved several immunotherapy and chemotherapy agents for the treatment of esophageal cancer. Notably, nivolumab (Opdivo) has been approved for adjuvant therapy in patients with residual pathologic disease following neoadjuvant chemoradiotherapy and surgery, based on the CheckMate 577 trial. Pembrolizumab (Keytruda) has also been approved for advanced or metastatic esophageal squamous cell carcinoma, particularly in patients with PD-L1-positive tumors, as demonstrated in the KEYNOTE-181 trial. These treatments focus on immune checkpoint inhibition, targeting the PD-1/PD-L1 pathway, which is similar to the immunotherapeutic approach being studied with agenT-797 in combination with other agents.

What other types of research exist?

Promising novel alternatives to agenT-797 for esophageal cancer patients include: 1) Combination therapies involving immune checkpoint inhibitors such as pembrolizumab or nivolumab, which have shown efficacy in various cancers including esophageal cancer. 2) CD137 agonists like urelumab, which enhance the activity of NK cells and dendritic cells. 3) CTLA4 blockade with ipilimumab, which can augment antitumor immunity. These therapies are being actively studied and have shown potential in clinical trials.

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Virus Therapy

Combination Therapy for Esophageal and Stomach Cancers

Phase 2

Recruiting

Led By Yelena Janjigian, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Disease progression on one prior line of therapy for metastatic disease

Patients must have histologically or cytologically confirmed esophageal, gastric, or gastroesophageal junction adenocarcinoma

Must not have

Received prior therapy with ramucirumab at any time

History of gastrointestinal perforation or fistulae

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of new and existing drugs to treat patients whose disease isn't responding well to standard treatments. The drugs work by either boosting the immune system or directly attacking cancer cells. The goal is to find more effective treatment options for these patients.

Who is the study for?

This trial is for individuals with certain types of cancer affecting the stomach, esophagus, or where they join together. Specific details on who can join are not provided here, but typically participants would need to meet certain health standards and have a diagnosis that matches the trial's focus.

What is being tested?

The study is testing a combination of treatments: agenT-797, botensilimab, balstilimab, ramucirumab, and paclitaxel in patients with esophageal or gastric cancers. The timing of each treatment may vary based on individual patient needs.

What are the potential side effects?

While specific side effects are not listed here, common ones for cancer treatments include fatigue, nausea, increased risk of infection due to weakened immune system responses from chemotherapy agents like paclitaxel.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has worsened after one treatment for its advanced stage.

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My cancer is confirmed to be in the esophagus, stomach, or where they meet.

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My cancer can be measured or evaluated for treatment response.

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I am 18 years old or older.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer is in the esophagus, stomach, or where they meet and cannot be removed by surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with ramucirumab before.

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I have had a gastrointestinal perforation or fistula.

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I have an active tuberculosis infection.

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I have cancer that has spread to my brain or its coverings.

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I have or had lung inflammation not caused by an infection.

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My nerve damage affects my daily activities.

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I have tested positive for HIV.

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I have been treated with paclitaxel or docetaxel in the last 6 months.

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I had a severe reaction to previous immunotherapy.

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I haven't taken immunosuppressive drugs or steroids in the last 7 days, except for replacement therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Response Rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Participants diagnoses with Esophageal, Gastric, or Gastro-esophageal Junction CancerExperimental Treatment5 Interventions

Participants with measurable disease and with evaluable disease as defined by RECIST v1.1 will be enrolled on this study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ramucirumab

2017

Completed Phase 3

~5050

Paclitaxel

2011

Completed Phase 4

~5450

0 / 16Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for esophageal cancer include immune checkpoint inhibitors, chemotherapy, and targeted therapies. Immune checkpoint inhibitors, such as nivolumab and pembrolizumab, work by blocking proteins like PD-1/PD-L1, which cancer cells use to evade the immune system, thereby enhancing the body's ability to fight cancer. Chemotherapy agents like paclitaxel and cisplatin kill rapidly dividing cancer cells by interfering with their DNA replication. Targeted therapies, such as ramucirumab, inhibit specific molecules involved in tumor growth and angiogenesis. These treatments are crucial for esophageal cancer patients as they offer multiple mechanisms to attack cancer cells, potentially improving outcomes and survival rates.