Cancer
Conditions
Interventions
Product Name: Not Applicable
Product Code: Not Applicable
Pharmaceutical Form:
Product Name: Not Applicable
Product Code: Not Applicable
Pharmaceutical Form:
Product Name: Not Applicable
Product C
Sponsors
Pfizer Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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; or - PD on 1st -line anti-PD-1/-L1 plus standard doublet platinumcontaining regimen followed by continuation of single agent anti-PD-1/- L1). 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; or - PD on 1st-line combination of avelumab with axitinib or pembrolizumab with axitinib. d. HR+ HER2- adenocarcinoma of the breast (Cohort 4): - PD on 1st-line combination of doublet palbociclib with hormonal therapy. e. Castrate-resistant adenocarcinoma of the prostate (Cohort 5): - PD on enzalutamide monotherapy. f. Castrate-resistant adenocarcinoma of the prostate (Cohort 6): - PD on abiraterone in combination with prednisone. g. germline mutated BRCA (gBRCAm), HER2- adenocarcinoma of the breast (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 and adequacy of an archival, formalin-fixed, paraffin embedded (FFPE) tumor tissue block confirmed during Screening as 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 45 days of obtaining informed consent for the 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 sub
Exclusion criteria
Exclusion criteria: 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) and a second-generation AR antagonist other than enzalutamide (eg, apalutamide). 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. 9. Austria only: Pregnant female patients; breastfeeding female patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To obtain and analyze archival pre-treatment tumor samples and post-progression tumor biopsies to identify molecular markers of resistance to selected anti-cancer therapies.;Secondary Objective: To evaluate the success rate in obtaining paired archival and post-progression tumor biopsies that are adequate to meet the objectives of the study; To determine concordance in gene alterations identified by NGS analysis of post-progression tumor tissue and blood.;Primary end point(s): Change in the frequency of gene alterations between pre-treatment tumor samples and post-progression tumor biopsies.;Timepoint(s) of evaluation of this end point: As the goal is to compare the differences in frequency of mutation rate between pre-treatment archival and post-progression samples, score based 95% Confidence Interval (CI ) for matched pairs will be calculated for each genomic alteration. Estimates of the frequency of mutations, the difference of the frequency of mutations between archival and post-progression samples and associated 95% CIs will be generated. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Proportion of patients with fully evaluable archival and post-progression tumor biopsy (eg, sample sufficient for all intended analyses at all measured time points); - Overall agreement rates of gene alterations between post-progression biopsy tissue and blood NGS results.;Timepoint(s) of evaluation of this end point: For the proportion of patients with fully evaluable archival and post-progression tumor biopsies, proportions and 95% CI will be calculated. For the overall agreement rates of gene alterations between post-progression biopsy tissue and blood NGS results, the frequency of mutations detected from post-progression biopsy tissue, blood and the corresponding 95% CIs will be generated. The concordance between both matched tissue biopsy tissue and blood samples and the 95% CI will also be calculated to evaluate the agreement. | — |
Countries
Argentina, Austria, European Union, Mexico, Spain, United States
Contacts
Public ContactClinical Trials.gov Call Center
Pfizer Inc.
Outcome results
None listed