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New Dual-Action antibodies take on tough esophageal cancer

NCT ID NCT04785820

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This phase 2 trial tested two experimental drugs, lomvastomig and tobemstomig, against the standard immunotherapy nivolumab in 190 people with advanced esophageal cancer that had worsened after chemotherapy. The drugs are bispecific antibodies designed to block two immune checkpoints at once, potentially boosting the immune system's attack on cancer cells. The study compared overall survival and side effects among the three groups.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
bispecific antibodies (lomvastomig and tobemstomig)
What this could lead to
If successful, these new drugs could offer a more effective treatment option for advanced esophageal cancer that has stopped responding to standard chemotherapy.
What could go wrong
This is an early-phase trial with only 190 participants, and one drug arm was stopped early for strategic reasons. The results may not lead to a new approved treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

190 people

The number who actually took part.

Started

Jun 2021

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Advanced or metastatic, histologically confirmed esophageal squamous-cell carcinoma (ESCC) * Patients who have previously received 1 line of treatment with either a fluoropyrimidine- and platinum- or a taxane- and platinum-based regimen in non-curative intention prior to randomization; or patients who received treatment with a fluoropyrimidine-/taxane- and platinum-based regimen in curative intention and had recurrence or progression within 24 weeks after the last dose of the treatment * Radiologically measurable disease according to RECIST v1.1. Previously irradiated lesions should not be counted as target lesions unless clearly progressed after the radiotherapy * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 * A life expectancy of at least (≥)12 weeks * Tissue samples must be provided for analysis of anti-programmed death ligand-1 (PD-L1) tumor positivity * Adverse events from any prior radiotherapy, chemotherapy, or surgical procedure must have resolved to Grade ≤1, except alopecia (any grade), vitiligo, endocrinopathy managed with replacement therapy, and Grade 2 peripheral neuropathy * Adequate cardiovascular, hematological, liver, and renal function * Serum albumin ≥25 grams per liter (g/L), * For participants not receiving therapeutic anticoagulation: prothrombin time (PT) and activated partial thromboplastin time ≤1.5 times (×) the upper limit of normal (ULN); for participants receiving therapeutic anticoagulation: stable anticoagulant regimen * A female participant is eligible to participate if she is not pregnant, not breastfeeding, not a woman of childbearing potential (WOCBP), or a WOCBP who agrees to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods during the treatment period and for at least 5 months after the final dose of study drug and have a negative pregnancy test (blood) within the 7 days prior to randomization. * A male participant must remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures such as a condom plus an additional contraceptive method and refrain from donating sperm during the treatment period and for at least 5 months after the final dose of study drug Exclusion Criteria: * Pregnancy, lactation, or breastfeeding * Known hypersensitivity to any of the components of RO7121661, RO7247669, or nivolumab, including but not limited to, hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies * Patients with significant malnutrition. Patients whose nutrition has been well controlled for ≥28 days prior to randomization may be enrolled * Evidence of complete esophageal obstruction not amenable to treatment * Higher risk of bleeding or fistula caused by esophageal lesions invading adjacent organs (aorta or tracheobronchial tree). Patients with manageable fistula may be included at the Investigator's discretion. * Symptomatic central nervous system (CNS) metastases * Spinal cord compression not definitively treated with surgery and/or radiation or without evidence that disease has been clinically stable for ≥14 days prior to randomization * Active or history of carcinomatous meningitis/leptomeningeal disease * Asymptomatic CNS primary tumors or metastases if they have requirement for steroids or enzyme inducing anticonvulsants in the last 28 days prior to randomization * Uncontrolled tumor-related pain. Participants requiring pain medication must be on a stable regimen at study entry * Active second malignancy (with some exceptions) * Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including diabetes mellitus, history of relevant pulmonary disorders, known autoimmune diseases or immune deficiency, or other diseases with ongoing fibrosis (such as scleroderma, pulmonary fibrosis, emphysema, neurofibromatosis, palmar/plantar fibromatosis, etc.). * Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent * Significant cardiovascular/cerebrovascular disease within 6 months prior to randomization * Known active or uncontrolled bacterial, viral, fungal, mycobacterial (including but not limited to tuberculosis \[TB\] and typical mycobacterial disease), parasitic, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with intravenous (IV) antibiotics or hospitalization (relating to the completion of the course of antibiotics, except if for tumor fever) within 28 days prior to randomization * Known clinically significant liver disease, including alcoholic hepatitis, cirrhosis, and inherited liver disease. * Major surgical procedure or significant traumatic injury (excluding biopsies) within 28 days prior to randomization, or anticipation of the need for major surgery during the course of the study * Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications * Dementia or altered mental status that would prohibit informed consent * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (expected to occur once monthly or more frequently) * Active or history of autoimmune disease or immune deficiency * Positive human immunodeficiency virus (HIV) test at screening * Positive hepatitis B surface antigen (HBsAg) or positive total hepatitis B core antibody (HBcAb) test at screening * Positive hepatitis C virus (HCV) antibody test at screening * Prior cancer therapy with any immunomodulatory agents including checkpoint inhibitors (CPIs; such as anti-PDL1/PD1, anti-CTLA-4, anti-LAG3, anti-TIM3) * Vaccination with live vaccines within 28 days prior to randomization, or anticipation that a live attenuated vaccine will be required during the study * Treatment with therapeutic oral or IV antibiotics within 14 days prior to randomization * Concurrent therapy with any other investigational drug (defined as treatment for which there is currently no regulatory authority approved indication) 28 days or 5 half-lives of the drug (whichever is shorter) prior to randomization * Treatment with immune-modulating and immune suppressive agents/medication 5 half-lives or 28 days (whichever is shorter) prior to randomization * Regular immunosuppressive therapy (i.e., for organ transplantation, chronic rheumatologic disease) * Radiotherapy within the last 28 days before start of study drug treatment is not allowed, with the exception of limited palliative radiotherapy * Prior treatment with adoptive cell therapies, such as chimeric antigen receptor T cells (CAR-T) therapies

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Conditions

The condition(s) this trial relates to.

esophageal squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced or metastatic esophageal squamous cell carcinoma

Contacts and locations

Locations

  • APHP - Hopital Saint Antoine

    Paris, 75571, France

  • Ac?badem Altunizade Hastanesi

    Istanbul, Turkey (Türkiye)

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department

    Erzurum, 25240, Turkey (Türkiye)

  • Azienda Sanitaria Universitaria Integrata di Udine - PO Universitario Santa Maria della

    Udine, Friuli Venezia Giulia, 33100, Italy

  • Bashkirian Republican Clinical Oncology Dispensary

    Ufa, Bashkortostan Republic, 450054, Russia

  • Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital

    Adana, 01230, Turkey (Türkiye)

  • Centre Leon Berard

    Lyon, 69373, France

  • Centro Oncologico Riojano Integral (CORI)

    La Rioja, F5300COE, Argentina

  • Centrum Onkologii w Bydgoszczy

    Bydgoszcz, 85-796, Poland

  • Changhua Christian Hospital

    Chang-hua, 500, Taiwan

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128, South Korea

  • Communal Non profit Enterprise Regional Center of Oncology

    Kharkiv, Kharkiv Governorate, 61070, Ukraine

  • Complejo Hospitalario de Navarra

    Pamplona, Navarre, 31008, Spain

  • Curie Oncology

    Singapore, 329563, Singapore

  • Dicle Uni Medical Faculty

    Diyarbakır, 10000, Turkey (Türkiye)

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00, Czechia

  • First Moscow State Medical University n.a. I.M. Sechenov

    Moscow, Moscow Oblast, 119991, Russia

  • Group of companies "Medci"

    Moskva, Moscow Oblast, 105229, Russia

  • Hopital Claude Huriez

    Lille, 59037, France

  • Hopital Timone Adultes

    Marseille, 13385, France

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Clínic i Provincial

    Barcelona, 08036, Spain

  • Hospital das Clinicas - UFRGS

    Porto Alegre, Rio Grande do Sul, Brazil

  • ICO Rene Gauducheau

    Saint-Herblain, 44805, France

  • IRCCS Istituto Oncologico Veneto (IOV)

    Padova, Veneto, 35128, Italy

  • Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department

    Malatya, 44280, Turkey (Türkiye)

  • Inst. Alexander Fleming

    Buenos Aires, C1426ANZ, Argentina

  • Institut régional du Cancer Montpellier

    Montpellier, 34298, France

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    São Paulo, São Paulo, 01246-000, Brazil

  • International Cancer Institute (ICI)

    Eldoret, 30100, Kenya

  • Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS

    Meldola, Emilia-Romagna, 47014, Italy

  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet

    Szolnok, 5004, Hungary

  • Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II

    Krakow, 31-202, Poland

  • MEDSI Clinical Hospital on Pyatnitsky Highway

    Moscow, Moscow Oblast, 143422, Russia

  • Masaryk?v onkologický ústav

    Brno, 656 53, Czechia

  • NIO im Marii Sklodowskiej-Curie

    Warsaw, 02-034, Poland

  • National Cancer Centre

    Singapore, 168583, Singapore

  • National Taiwan University Hospital

    Zhongzheng Dist., 10048, Taiwan

  • Nottingham City Hospital

    Nottingham, NG5 1PB, United Kingdom

  • Odense Universitetshospital, Onkologisk Afdeling R

    Odense C, 5000, Denmark

  • Ramathibodi Hospital

    Bangkok, 10400, Thailand

  • Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary

    Sumy, 40005, Ukraine

  • Rigshospitalet

    København Ø, 2100, Denmark

  • Seoul National University Bundang Hospital

    Seongnam-si, 13605, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • Siriraj Hospital

    Bangkok, 10700, Thailand

  • Songklanagarind Hospital

    Songkhla, 90110, Thailand

  • Szpital Morski im. PCK

    Gdynia, 81-519, Poland

  • Taipei Veterans General Hospital

    Taipei, 112201, Taiwan

  • The Aga Khan University-Kenya.

    Nairobi, 00100, Kenya

  • Van Yuzuncu Yil University Hospital

    Van, Turkey (Türkiye)