Combining Nivolumab and Cetuximab after Chemoradiation for Esophageal Cancer
A Phase II Study of the Addition of Nivolumab and Cetuximab to Chemoradiation in Locally Advanced Esophageal Squamous Cell Carcinoma (ESqCC).
This study is testing if adding two drugs, nivolumab and cetuximab, after chemotherapy and radiation can help people with advanced esophageal cancer before surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 31 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rabin Medical Center Academic / other |
| Drugs / interventions | chemotherapy, radiation, nivolumab, cetuximab, immunotherapy |
| Locations | 1 site (Petach Tikva) |
| Trial ID | NCT04229459 on ClinicalTrials.gov |
What this trial studies
This phase II, open-label, two-centered trial evaluates the effectiveness of adding nivolumab and cetuximab after chemoradiation in patients with locally advanced esophageal squamous cell carcinoma. Eligible participants will undergo a regimen that includes induction chemotherapy with cetuximab, followed by chemoradiation and then immunotherapy with nivolumab and cetuximab before surgery. The study aims to assess the safety and efficacy of this treatment approach in patients who have not received prior treatment for esophageal cancer.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with operable, primary locally advanced esophageal squamous cell carcinoma who have not received prior treatment.
Not a fit: Patients with recurrent esophageal cancer or those who have previously undergone systemic or radiation therapy for esophageal cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve outcomes for patients with locally advanced esophageal squamous cell carcinoma.
How similar studies have performed: Other studies have shown promise in using immunotherapy in combination with chemotherapy and radiation for various cancers, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signed written IRB approved informed consent. * Age \> 18 years. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 * Subjects with histologically confirmed operable, primary (non-recurrent) locally advanced (T3NxM0, TxN1M0) middle (distal to the thoracic inlet) or distal (up to the gastroesophageal junction) ESqCC according to endoscopic ultrasound (EUS) and PET-CT. * No prior systemic or radiation therapy for esophageal cancer. * Presence of adequate contraception in fertile patients. * Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug. * Women must not be breastfeeding. * No previous (within the last 5 years) or concurrent malignancies, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix or basal cell carcinoma of the skin. Exclusion Criteria: * Cervical esophageal tumors or tumors \< 5 cm from the cricopharyngeal cartilage. * Gastric cancers with minor involvement of the GEJ or distal esophagus, or an esophageal tumor extending beyond 2 cm into the stomach. * Prior chest or upper abdomen radiotherapy, prior systemic chemotherapy within the past 5 years or prior esophageal or gastric surgery. * Patients with evidence of metastatic disease. * Biopsy proven tumor invasion of the tracheobronchial tree or presence of tracheo-esophageal (TE) fistula or recurrent laryngeal nerve or phrenic nerve paralysis. * New York Heart Association Class III or IV heart disease. Angina or myocardial infarction within the last 12 months, history of significant ventricular arrhythmia requiring medication with antiarrhythmics, or a history of a clinically significant conduction system abnormality. * Clinically significant hearing loss. * Patients with a history of seizure disorder who are receiving phenytoin, phenobarbital, or other antiepileptic medication. * Any positive test for hepatitis B virus or hepatitis C virus indicating active infection. * Ongoing immunosuppressive therapy. * Active autoimmune disease. \[Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll\]. * Prior organ transplant. * Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. * Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
Where this trial is running
Petach Tikva
- Rabin Medical Center — Petach Tikva, Israel (Recruiting)
Study contacts
- Principal investigator: Baruch Brenner, Prof — Rabin Medical Center
- Study coordinator: Baruch Brenner, Prof
- Email: brennerb@clalit.org.il
- Phone: 972-3-9378002
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.