Neoadjuvant Treatment in Rectal Cancer With Radiotherapy Followed by Atezolizumab and Bevacizumab (TARZAN)

Netherlands Cancer Institute (NKI)

Status and phase: Active, not recruiting; Phase 2

Conditions: Rectal Cancer

Treatments: Drug: Atezolizumab; Drug: Bevacizumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04017455

N18TRZ

Details and patient eligibility

About

In this study, patients with resectable rectal cancer will receive radiotherapy, followed by neoadjuvant bevacizumab and atezolizumab

Full description

38 patients with resectable rectal cancer will be enrolled. All patients will be treated with radiotherapy followed by bevacizumab and atezolizumab.

Enrollment: 38 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• signed informed consent
• patients age 18 years and older
• histologically confirmed adenocarcinoma of the rectum
• intermediate risk rectal cancer or low risk distal rectal cancer

Exclusion criteria

• evidence of metastatic disease
• prior radiation therapy for disease under study
• prior treatment with CD137 agonists or immune checkpoint blockade therapies
• current or recent use of acetylsalicylic acid
• history of clinically significant cardiac or pulmonary dysfunction pregnancy or breastfeeding
• significant auto-immune disease

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

bevacizumab and atezolizumab

Experimental group

Description:

1 cycle of bevacizumab monotherapy, followed by 2 cycles of bevacizumab combined with atezolizumab, followed by 1 cycle of atezolizumab monotherapy

Treatment:

Drug: Bevacizumab

Drug: Atezolizumab