eoadjuvant treatment in rectal cancer with radiotherapy followed by atezolizumab and bevacizumab (TARZAN)

Phase 1

• Conditions: adenocarcinoma of the rectum; MedDRA version: 20.0Level: PTClassification code 10038038Term: Rectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-002463-25-NL
• Lead Sponsor: Antoni van Leeuwenhoek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-29
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

- Signed informed consent form
- Age =18 years
- Able to comply with the study protocol, in the investigator’s judgment
- Histologically confirmed adenocarcinoma of the rectum, and known microsatellite stability status
- Patients with intermediate risk rectal cancer (cT1-3N1 or cT3N0 with extramural invasion >5 mm, distance to MRF >1 mm) or
Low risk distal rectal cancer (cT1-3N0, extramural invasion tot =5 mm, distance to MRF >1 mm) in patients who wish to pursue organ preservation
- No signs of distant metastases
- patients must be willing to undergo proctoscopy and biopsies prior to start of treatment and during treatment at defined timepoints
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Life expectancy > 6 months
- Evaluable disease
- Adequate hematologic and end-organ function

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

- Clinical symptoms or radiological suspicion of perforation
- Other malignancies within 3 years prior to registration in the study with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year overall survival > 90%) treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent).
- Prior radiation therapy within 30 days prior to C1D1 and/or persistence of radiation-related adverse effects or previous radiation therapy preventing 5x5Gy as specified in this study
- Prior allogeneic bone marrow transplantation or solid organ transplant for another malignancy in the past
- Spinal cord compression not definitively treated with surgery and/or radiation
- Treatment with any investigational agent or approved therapy within 28 days or two investigational agent half-lives (whichever is longer) prior to C1D1
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-PD-1 and anti-PD-L1, with MEK inhibitor or VEGF/VEGFR inhibitors
- History of clinically significant cardiac or pulmonary dysfunction
- Autoimmune conditions
- Infectious diseases

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified