Actively Recruiting
Pembrolizumab With Ataluren in Patients With Metastatic pMMR and dMMR Colorectal Carcinoma or Metastatic dMMR Endometrial Carcinoma: the ATAPEMBRO Study
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2023-02-01
47
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
A
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Single Center, open label, Phase I-II trial designed to test the safety and efficacy of the combination of Ataluren and Pembrolizumab for the treatment of metastatic mismatch repair deficient and proficient colorectal adenocarcinoma and metastatic mismatch repair deficient endometrial carcinoma.
CONDITIONS
Official Title
Pembrolizumab With Ataluren in Patients With Metastatic pMMR and dMMR Colorectal Carcinoma or Metastatic dMMR Endometrial Carcinoma: the ATAPEMBRO Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least one lesion with measurable disease defined by 10mm longest diameter for soft tissue or 15mm short axis for lymph nodes by RECIST 1.1 and irRC criteria
- Received at least one prior cancer therapy for metastatic colorectal cancer or refused palliative chemotherapy with documentation
- Life expectancy greater than 3 months
- Normal organ and marrow function as defined in the protocol
- Able and willing to provide written informed consent
- At least 18 years old at the time of consent
- Willing to provide tissue from a new pre-treatment biopsy of metastatic tumor and primary tumor if available; archived specimen allowed if new sample not feasible
- Willing to provide tissue post-treatment biopsy of metastatic tumor or primary tumor if available
- Performance status of 0 or 1 on the ECOG scale
- Female of childbearing potential must have negative pregnancy test within 72 hours before first dose
- Male subjects of childbearing potential must agree to use contraception from first dose through 120 days after last dose
You will not qualify if you...
- Known active central nervous system metastases or carcinomatous meningitis, unless stable without progression for at least 4 weeks and no steroid use for at least 1 week
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX-40, anti-CD40, or anti-CTLA-4 antibodies
- Use of growth factors (e.g., G-CSF, GM-CSF, erythropoietin) within 2 weeks before study drug or during study
- Uncontrolled illness including active infection, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting compliance
- History of autoimmune disease such as inflammatory bowel disease, rheumatoid arthritis, systemic sclerosis, lupus, autoimmune vasculitis, or autoimmune neuropathies; thyroid disease allowed
- Immunodeficiency or systemic steroid or immunosuppressive therapy within 7 days before first dose
- Known active tuberculosis
- Hypersensitivity to pembrolizumab, ataluren, or their excipients
- Prior monoclonal antibody cancer therapy within 4 weeks or unresolved adverse events from earlier treatments
- Prior chemotherapy, targeted therapy, or radiation within 2 weeks or unresolved adverse events
- Additional malignancy that is progressing or requires active treatment except certain skin and cervical cancers
- Active autoimmune disease requiring systemic treatment in past 2 years (replacement therapy allowed)
- Known or active non-infectious pneumonitis
- Active infection requiring systemic therapy
- Conditions or therapies that could interfere with study participation or results
- Psychiatric or substance abuse disorders interfering with study cooperation
- Pregnant, breastfeeding, or intending to conceive/father children during study and 120 days after last dose
- Known HIV infection
- Active Hepatitis B or C infection
- Live vaccine within 30 days before study start
- Aminoglycoside antibiotics within 3 days before study start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Amsterdam UMC, AMC
Amsterdam, North Holland, Netherlands, 1105 AZ
Actively Recruiting
Research Team
A
Adriaan D Bins, MD PhD
CONTACT
I
Ide T Spaanderman, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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