TREATMENT RESISTANCE FOLLOWING ANTI-CANCER THERAPIES (TRANSLATE)
- Conditions
- CancerTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-003612-45-ES
- Lead Sponsor
- Pfizer Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 550
1. Histological diagnosis of locally advanced (primary or recurrent) or metastatic solid tumors treated as follows:
a. NSCLC monotherapy (Cohort 1):
- Disease progression (PD) on 1st-line monotherapy anti-PD-1/-L1.
b. NSCLC combination (Cohort 2):
- PD on 1st-line anti-PD-1/-L1 plus standard doublet platinum-containing regimen.
c. Renal cell carcinoma (RCC) with clear cell component (Cohort 3):
- PD on 2nd-line monotherapy anti-PD-1/-L1; or
- PD on 1st-line combination of doublet anti- PD-1/-L1 with anti-CTLA-4.
d. HR+ HER2- breast cancer (Cohort 4):
- PD on 1st-line combination of doublet palbociclib with hormonal therapy.
e. Castrate-resistant prostate cancer (Cohort 5):
- PD on enzalutamide monotherapy.
f. Castrate-resistant prostate cancer (Cohort 6):
- PD on abiraterone in combination with prednisone.
g. germline mutated BRCA (gBRCAm), HER2- breast cancer (Cohort 7):
- PD on a PARP inhibitor monotherapy in patients previously treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting.
2. Radiographic evidence of PD, including the target lesion being subjected to biopsy for the study, on the most recent regimen that requires a change in anti-cancer treatment.
3. Medically stable for a biopsy procedure as defined by the local institutional
guidelines.
4. A tumor lesion for the de novo biopsy that meets the following criteria:
a. Is safely accessible to a biopsy procedure (ie, core needle, excisional) performed in accordance with local institutional practice standards;
b. Is anticipated to yield an amount of tumor tissue sufficient to meet the objectives of the study;
c. Not previously irradiated;
d. Does not require decalcification for subsequent processing.
5. Availability of an archival, formalin-fixed, paraffin embedded (FFPE) tumor tissue block containing sufficient tumor tissue to allow for sectioning of up to 25 slides each containing tissue sections that are 5 microns thick with a minimum tissue cross-sectional area of approximately 5 mm2 and containing a minimum of approximately 20-40% tumor by ratio of tumor nuclei to benign nuclei. Fewer
slides may be required for FFPE tissue blocks containing tissue that is greater than 5 mm2 in cross-sectional area or greater than 40% tumor. Where local or regional regulations prevent submission of the archival tumor tissue block, a designated number of unstained slides each containing the indicated minimum amount of tissue must be submitted (refer to the Laboratory Manual for the required number of slides based on cross sectional area of tissue available in the FFPE tissue block) .
6. Post-progression biospecimen collection can be performed within 21 days of obtaining informed consent for the main study.
7. Post-progression biospecimen collection can be performed within 45 days of the last dose of the most recent anti-cancer regimen.
8. Age >=18 years at the time of informed consent.
9. Patients who are willing and able to comply with scheduled visits and study procedures.
10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
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 220
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 330
1. Discontinuation of current or most recent anti-cancer therapy due to toxicity and not progressive disease.
2. Initiation of new anti-cancer therapy after PD prior to planned biopsy.
3. Any medical condition that, in the investigator’s judgement, unacceptably increases risk associated with the tumor biopsy or blood sampling procedures (eg, evidence of inadequate wound healing, significant neutropenia or thrombocytopenia, recent
history of clinically significant bleeding or tumor hemorrhage).
4. Cohorts 1, 2 and 3 (NSCLC monotherapy, NSCLC combination, RCC with clear cell component) only: Treatment with an anti-PD-1/-L1 agent prior to current or most recent anti-PD-1/-L1 therapy.
5. Cohort 4 (HR+ HER2- breast cancer) only: Treatment with a CDK 4/6 inhibitor prior to current or most recent CDK 4/6 inhibitor.
6. Cohort 5 (castrate-resistant prostate cancer) only: Treatment with an agent that blocks adrenal androgen synthesis (eg, abiraterone acetate) or second-generation AR antagonist.
7. Patients who are investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or patients who are Pfizer employees, including their family members, directly involved in the conduct of the study.
8. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method