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Study of RO7121661, RO7247669, and Nivolumab for Patients with Advanced or Metastatic Esophageal Squamous Cell Carcinoma

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer called advanced or metastatic squamous cell carcinoma of the esophagus. This is a condition where cancer cells form in the tissues of the esophagus, which is the tube that carries food from the mouth to the stomach. The study is testing two new treatments, RO7121661 and RO7247669, which are special proteins designed to help the immune system fight cancer. These treatments are being compared to an existing medication called nivolumab, which is already used to treat this type of cancer.

The purpose of the study is to see how well these new treatments work in helping patients live longer. Participants in the study will be randomly assigned to receive either RO7121661, RO7247669, or nivolumab. The study is designed to be "blinded," meaning that neither the participants nor the researchers will know which treatment each participant is receiving, to ensure unbiased results. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the treatments more accurately.

Throughout the study, participants will receive their assigned treatment through an intravenous infusion, which means the medication is given directly into a vein. The study will monitor the participants' overall health and any side effects they may experience. The goal is to determine which treatment is most effective in improving survival and quality of life for people with this type of esophageal cancer. The study will continue for a period of time to gather enough information to make a clear comparison between the treatments.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, participation is confirmed based on specific criteria, including having a measurable disease and adequate organ function.

    The study involves individuals with advanced or metastatic squamous cell carcinoma of the esophagus.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of three groups to receive different treatments.

    The treatments include RO7121661, RO7247669, or nivolumab.

  3. Step 3

    Treatment administration

    The medication RO7247669 is administered as a solution for infusion through an intravenous route.

    The frequency and dosage of the medication are determined by the study protocol and medical team.

  4. Step 4

    Monitoring and assessments

    Regular monitoring is conducted to assess the treatment's effects and any side effects.

    Assessments include measuring overall survival, response to treatment, and quality of life improvements.

  5. Step 5

    Completion of treatment

    The treatment phase continues until the study's end date or until specific criteria for discontinuation are met.

    The estimated end date for the study is June 30, 2025.

  6. Step 6

    Follow-up

    After completing the treatment, follow-up assessments are conducted to monitor long-term effects and overall health.

    These assessments help in understanding the treatment's impact over time.

Who can join the trial?

9 criteria

  • The patient must have a type of cancer called advanced or metastatic squamous cell carcinoma of the esophagus.
  • The patient must have a disease that can be measured using special imaging tests. If the patient had radiation treatment before, those areas should not be counted unless the disease has clearly gotten worse after the treatment.
  • The patient must have a Performance Status of 0-1 according to the Eastern Cooperative Oncology Group (ECOG). This is a scale that helps doctors understand how well a patient can perform daily activities.
  • Any side effects from previous treatments like radiation, chemotherapy, or surgery must have improved to a mild level, except for hair loss, skin changes like vitiligo, hormone issues managed with medication, and moderate nerve problems in the hands or feet.
  • The patient must have good blood health, which means their blood cells are functioning well.
  • The patient must have good liver health, meaning their liver is working properly.
  • The patient must have good kidney health, meaning their kidneys are functioning well.
  • The patient must be an adult, as the study includes people aged 18 and older.
  • Both men and women can participate in the study.

Who cannot join the trial?

7 criteria

  • Patients with other types of cancer besides the specific type being studied cannot participate.
  • Patients who have received certain treatments for their cancer recently may not be eligible.
  • Patients with severe or uncontrolled medical conditions that could interfere with the study are excluded.
  • Patients who are pregnant or breastfeeding cannot take part in the study.
  • Patients who have participated in another clinical trial within a certain time frame may not be eligible.
  • Patients with known allergies to the study medication or similar drugs are excluded.
  • Patients who are unable to comply with the study procedures and follow-up visits cannot participate.
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Investigated drugs

  • RO7121661

    is a bispecific antibody that targets two proteins, PD1 and TIM3. It is designed to help the immune system recognize and attack cancer cells more effectively. This medication is being tested to see if it can improve outcomes for patients with advanced or metastatic squamous cell carcinoma of the esophagus.

  • RO7247669

    is another bispecific antibody that targets PD1 and LAG3. Like RO7121661, it aims to enhance the immune system's ability to fight cancer by blocking these proteins, which can help the body better identify and destroy cancer cells. This study is evaluating its effectiveness in improving survival rates for patients with this type of esophageal cancer.

  • Nivolumab

    is a medication that works by blocking the PD1 protein on immune cells. This action helps the immune system to detect and attack cancer cells. It is already used in various cancer treatments and is being used in this trial as a comparison to the new investigational drugs.

What is already known about the treatment

  • RO7121661

    This medication is administered as an injection and is currently being studied in clinical trials. It is a bispecific antibody targeting PD1 and TIM3, designed to help the immune system recognize and attack cancer cells. The main therapeutic indication is for advanced or metastatic squamous cell carcinoma of the esophagus. It works by blocking specific proteins that prevent the immune system from effectively targeting cancer cells, thereby enhancing the body's immune response against the tumor.

  • RO7247669

    This medication is also administered as an injection and is under investigation in clinical trials. It is a bispecific antibody targeting PD1 and LAG3, aimed at treating advanced or metastatic squamous cell carcinoma of the esophagus. The mechanism of action involves inhibiting proteins that suppress immune activity, thus boosting the immune system's ability to fight cancer. It is part of a class of drugs known as immune checkpoint inhibitors, which are designed to enhance the body's natural defenses against cancer.

  • Nivolumab

    This medication is given as an injection and is an established treatment in the field of oncology. It is an immune checkpoint inhibitor that targets the PD1 protein, used to treat various types of cancer, including advanced or metastatic squamous cell carcinoma of the esophagus. Nivolumab works by blocking the PD1 pathway, which can help the immune system detect and destroy cancer cells more effectively. It is widely recognized in medical literature for its role in cancer immunotherapy.

Investigated diseases

Squamous Cell Carcinoma of the Esophagus – This is a type of cancer that begins in the flat cells lining the esophagus, the tube that carries food from the throat to the stomach. It is characterized by the abnormal growth of these squamous cells, which can form a tumor. As the disease progresses, the tumor may grow and invade deeper layers of the esophagus and potentially spread to nearby tissues or other parts of the body. Symptoms often include difficulty swallowing, weight loss, and chest pain. The disease is more common in certain regions and populations, often linked to lifestyle factors such as smoking and alcohol consumption. Early detection can be challenging, as symptoms may not appear until the disease is advanced.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511403-41-00Protocol codeBP42772Estimated enrolment230 patientsSponsorF. Hoffmann-La Roche AG

sourced from the EU Clinical Trials Register and site verification

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