Second-line Cabozantinib and Atezolizumab in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

NCT05007613 | Completed Phase 2 FDA Drug

• 1 other identifier: 202101041MIPB
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

To demonstrate that combination of cabozantinib and atezolizumab is safe and efficacious in patients with recurrent/metastatic esophageal squamous cell carcinoma.

Conditions

Esophageal Cancer; Metastatic Cancer; Squamous Cell Carcinoma

Keywords

esophageal cancer; squamous cell carcinoma; cabozantinib; atezolizumab; immune checkpoint inhibitor

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  Overall response rate (ORR) is the proportion of patients whose tumor is significantly reduced.

  at least 3 weeks after the first treatment

Secondary Outcomes (3)

• Progression-free survival

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

• Overall survival

  From date of randomization until the date of death from any cause, assessed up to 60 months

• Safety (treatment-related adverse effects)

  From the first treatment to 30 days after the end of study.

Study Arms (1)

cabozantinib plus atezolizumab

EXPERIMENTAL

cabozantinib 40mg PO QD atezolizumab 1200mg IVD 30-60mins Q3W

Drug: Cabozantinib 40 MG; Drug: Atezolizumab Injection

Interventions

Cabozantinib 40 MG DRUG

Cabozantinib (Cabometyx) 40 MG PO QD

Also known as: Cabometyx

cabozantinib plus atezolizumab

Atezolizumab Injection DRUG

atezolizumab (Tecentriq) 1200mg IVF 30-60mins Q3W

Also known as: Tecentriq

cabozantinib plus atezolizumab

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven squamous cell carcinoma of esophagus.
• Progression from first-line platinum-based chemotherapy for recurrent or metastatic ESCC, or progression within 6 months after neoadjuvant, definitive, or adjuvant chemo(radio) -therapy for loco-regional ESCC.
• Measurable disease per RECIST 1.1
• Recovery to baseline or ≤ Grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy as determined by the Investigator.
• Age twenty years or older
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• The subject is receiving antiviral therapy per local standard of care if the subject has active HBV infection (defined by HBsAg positive); the subject must have HBV DNA \< 500 IU/mL.Patients with HBV infection are required to continue antiviral therapy throughout the Treatment Period, and till at least 3 months after discontinuing Trial treatment.
• Adequate organ and marrow function, based upon meeting all of the following laboratory criteria within 14 days prior to treatment:
• Absolute neutrophil count (ANC) ≥ 1500/µL without granulocyte colony-stimulating factor support within 2 weeks before screening laboratory sample collection.
• White blood cell (WBC) count ≥ 2500/µL.
• Platelets ≥ 100,000/µL without transfusion within 2 weeks before screening laboratory sample collection.
• Hemoglobin ≥ 9 g/dL without transfusion within 2 weeks before screening laboratory sample collection.
• Alanine aminotransferase (ALT), AST, and alkaline phosphatase (ALP) ≤ 3 × upper limit of normal (ULN).
• Total bilirubin ≤ 1.5 mg/dL.
• Serum albumin ≥ 2.8 g/dL.

You may not qualify if:

• Previously treated with PD-1/PD-L1 blockade or any type of small molecule kinase inhibitor (including investigational kinase inhibitor)
• Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment.
• Prior radiotherapy regimen exceeding 70 Gy for a single site, including ESCC or other metastatic sites:
• For radiotherapy to treat ESCC:
• If the radiation is combined with chemotherapy, a minimum of 4 months must elapse between the end of radiotherapy and registration. If the radiation is given alone, a minimum of 8 weeks must elapse between the end of radiotherapy and registration.
• For radiotherapy to treat metastatic site:
• A minimum of 3 weeks must elapse between prior radiation and registration.
• All treatment areas should be fully healed with no sequelae from RT that would predispose to fistula formation. Unhealed or with sequelae from RT that would predispose to fistula formation.
• Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of first dose of study treatment.
• Concomitant anticoagulation with oral anticoagulants (eg, warfarin, direct thrombin and Factor Xa inhibitors) or platelet inhibitors (eg, clopidogrel), except for the following allowed anticoagulants:
• Low-dose aspirin for cardioprotection (per local applicable guidelines) is permitted.
• Low-dose low molecular weight heparins (LMWH) are permitted.
• Anticoagulation with therapeutic doses of LMWH is allowed in subjects without known brain metastases who are on a stable dose of LMWH for at least 6 weeks before first dose of study treatment, and who have had no clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor.
• Administration of a live, attenuated vaccine within 30 days prior to treatment.
• Any subject who cannot be evaluated by computed tomography (CT) because of allergy or other contraindication to both CT and MRI contrast agents.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Ipsen: collaborator
• Roche Pharma AG: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Neoplasm Metastasis; Carcinoma, Squamous Cell

Interventions

cabozantinib; atezolizumab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: cabozantinib and atezolizumab

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: August 16, 2021
• Study Start: June 23, 2021
• Primary Completion: July 17, 2024
• Study Completion: December 1, 2024
• Last Updated: January 1, 2025

Record last verified: 2024-12

Locations

TW (1)