Combining Ataluren with immunotherapy for the treatment of colorectal and endometrial cancer: the ATAPEMBRO study.

Phase 1

• Conditions: Mismatch repair deficient and proficient metestatic colorectal carcinoma and mismatch repair deficient metastatic endometrial carcinoma; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-004752-34-NL
• Lead Sponsor: Amsterdam University Medical Centers location AMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-18
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 47

Inclusion Criteria

- Metastatic or irresectable locally advanced mismatch repair proficient or deficient colorectal carcinoma or mismatch repair deficient endometrial carcinoma
- Have received or refused at least one chemotherapy treatment for metastatic disease
- Life expectancy greater than 3 months
- Normal organ and marrow function (as defined in protocol)
- Be willing and able to provide metastasis tissue pre and post treatment by core or excissional biopsy.
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 17
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

- (Partner is) currently pregnant or breastfeeding or is planning to become pregnant or nurture a child during the duration of the trial and a designated period thereafter.
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti OX-40, anti-CD40 or anti-CTLA-4.
- Active central nervous system metastsasis or carcinomateus meningitis
- (History of) auto-immune disease
- Immunodeficiency or use of immunosuppressing drugs.
- Active infection
- Uncontrolled intercurrent disease (for example hearth failure)
- (History of) active Tuberculosis
- HIV, Hep A, Hep B.

Study & Design

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