<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04436120</url>
  </required_header>
  <id_info>
    <org_study_id>A9001502</org_study_id>
    <secondary_id>TRANSLATE</secondary_id>
    <secondary_id>2018-003612-45</secondary_id>
    <nct_id>NCT04436120</nct_id>
  </id_info>
  <brief_title>Treatment Resistance Following Anti-cancer Therapies</brief_title>
  <official_title>TREATMENT RESISTANCE FOLLOWING ANTI-CANCER THERAPIES (TRANSLATE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The TRANSLATE study aims to better understand why tumors become resistant to standard&#xD;
      anti-cancer therapies.&#xD;
&#xD;
      New tumor biopsy and blood samples are collected after disease progression on&#xD;
      standard-of-care anti-cancer treatment and compared to the initial (archival) tumor biopsy&#xD;
      sample taken from the same patient.&#xD;
&#xD;
      Annotated reports of results from clinical Next Generation Sequencing (NGS) gene panel tests&#xD;
      of both tumor and blood are sent directly from the testing lab to the study physician for&#xD;
      discussion with the patient during the study.&#xD;
&#xD;
      Patients may participate in interventional treatment clinical trials at the same time as&#xD;
      participating in the TRANSLATE study.&#xD;
&#xD;
      Primary data will be publicly available after the study to support further research.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Development of new cancer treatments requires better understanding of why tumors&#xD;
      develop resistance to standard-of-care (SOC) therapies. However, post-progression tumor&#xD;
      biopsies are not routinely collected, limiting the tissue available to characterize&#xD;
      mechanisms of treatment resistance. The TRANSLATE clinical study is specifically designed to&#xD;
      address these critical gaps.&#xD;
&#xD;
      Trial design: TRANSLATE is a global, multicenter, translational study designed to collect and&#xD;
      compare archival pre-treatment tumor tissue with paired de novo tumor and blood samples&#xD;
      obtained following disease progression on SOC therapies, targeting therapeutically important&#xD;
      areas of cancer biology.&#xD;
&#xD;
      Eligible Tumor Type and Most Recent SOC Therapy:&#xD;
&#xD;
        -  Non-small-cell lung and Anti-PD-1/-L1 monotherapy&#xD;
&#xD;
        -  Non-small-cell lung and Anti-PD-1/-L1 + platinum&#xD;
&#xD;
        -  Clear cell renal cell carcinoma and Anti-PD-1/-L1 monotherapy&#xD;
&#xD;
        -  Clear cell renal cell carcinoma and Doublet anti-PD-1/-L1 + anti-CTLA-4&#xD;
&#xD;
        -  Clear cell renal cell carcinoma and Pembrolizumab + axitinib&#xD;
&#xD;
        -  Clear cell renal cell carcinoma and Avelumab + axitinib&#xD;
&#xD;
        -  HR+ HER2- breast and Palbociclib + hormonal therapy&#xD;
&#xD;
        -  germline mutated BRCA breast and Olaparib or talazoparib monotherapy&#xD;
&#xD;
        -  Castration-resistant prostate and Enzalutamide&#xD;
&#xD;
        -  Castration-resistant prostate and Abiraterone + prednisone&#xD;
&#xD;
      Eligibility criteria include adults with locally advanced or metastatic tumors; radiographic&#xD;
      evidence of progressive disease during the most recent SOC regimen; sufficient archival tumor&#xD;
      tissue; and a post-progression tumor lesion that is safely accessible for a new biopsy.&#xD;
&#xD;
      The results from clinical NGS panel testing may help inform subsequent treatment plan or&#xD;
      identification of relevant interventional clinical trials.&#xD;
&#xD;
      Patients are enrolled after disease progression on SOC and before change in treatment and&#xD;
      participate in 3 study visits within approximately 3 months.&#xD;
&#xD;
      Next-generation sequencing results from analysis of tumor tissue and blood will be returned&#xD;
      to the study physician and patient for review at a subsequent study visit within this&#xD;
      timeframe.&#xD;
&#xD;
      The primary endpoint is the change in frequency of gene alterations between pre-treatment and&#xD;
      post-progression tumor biopsies. Secondary endpoints address prioritized scientific&#xD;
      hypotheses specific to each target area of biology and indication.&#xD;
&#xD;
      Primary data will be publicly available after the study to support further research.&#xD;
&#xD;
      Sponsored by Pfizer Inc.; EudraCT: 2018-003612-45.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study terminated due to lack of enrollment that has been compounded by the global COVID-19&#xD;
    pandemic. There were no safety and/or efficacy concerns involved in the decision to stop&#xD;
    enrollment.&#xD;
  </why_stopped>
  <start_date type="Actual">February 13, 2019</start_date>
  <completion_date type="Actual">December 14, 2020</completion_date>
  <primary_completion_date type="Actual">December 14, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the frequency of gene alterations between pre treatment tumor samples and post progression tumor biopsies</measure>
    <time_frame>Through study completion, approximately 3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with fully evaluable archival and post progression tumor biopsy (eg, sample sufficient for all intended analyses at all measured time points)</measure>
    <time_frame>Through study completion, approximately 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concordance of gene alterations between post progression biopsy tissue and blood NGS results</measure>
    <time_frame>Through study completion, approximately 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the frequency of alterations in genes encoding HLA, Beta-2 Microglobulin, STAT1, JAK1, JAK2, IFN-gamma and IFN- gamma R between pre treatment archival and post progression samples</measure>
    <time_frame>Through study completion, approximately 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of alterations in genes encoding HLA, Beta 2 Microglobulin, STAT1, JAK1, JAK2, IFN-gamma and IFNGR in cfDNA</measure>
    <time_frame>Through study completion, approximately 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the frequency of RB1 gene alterations between pre treatment archival and post progression samples</measure>
    <time_frame>Through study completion, approximately 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of RB1 gene alterations in cfDNA</measure>
    <time_frame>Through study completion, approximately 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the frequency of AR gene alterations between pre treatment archival and post progression samples</measure>
    <time_frame>Through study completion, approximately 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of AR gene alterations in cfDNA</measure>
    <time_frame>Through study completion, approximately 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the expression of nuclear hormone receptors or related RNA signatures reflecting nuclear receptor pathway activity between pre treatment archival and post progression samples</measure>
    <time_frame>Through study completion, approximately 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the frequency of somatic reversion alterations in gBRCA mutant allele between pre treatment archival and post progression samples</measure>
    <time_frame>Through study completion, approximately 3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Disease Progression</condition>
  <arm_group>
    <arm_group_label>Tumor biopsy and blood draw</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Tumor biopsy and blood draw</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>De novo tumor tissue biopsy</intervention_name>
    <description>De novo tissue biopsy performed following disease progression</description>
    <arm_group_label>Tumor biopsy and blood draw</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Research blood draws</intervention_name>
    <description>Blood biospecimens collected following disease progression</description>
    <arm_group_label>Tumor biopsy and blood draw</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histological diagnosis of locally advanced (primary or recurrent) or metastatic solid&#xD;
             tumors treated as follows:&#xD;
&#xD;
          -  Non small cell lung carcinoma (NSCLC) monotherapy: Disease progression (PD) on 1st&#xD;
             line monotherapy anti PD-1/ L1.&#xD;
&#xD;
          -  NSCLC combination: PD on 1st line anti PD-1/ L1 plus standard doublet platinum&#xD;
             containing regimen; or PD on 1st-line anti-PD-1/-L1 plus standard doublet&#xD;
             platinum-containing regimen followed by continuation of single agent anti-PD-1/-L1).&#xD;
&#xD;
          -  Renal cell carcinoma (RCC) with clear cell component: PD on 2nd line monotherapy anti&#xD;
             PD-1/ L1; or PD on 1st line combination of doublet anti-PD-1/ L1 with anti-CTLA-4; or&#xD;
             PD on 1st-line combination of avelumab with axitinib or pembrolizumab with axitinib.&#xD;
&#xD;
          -  HR+ HER2 adenocarcinoma of the breast: PD on 1st line combination of doublet&#xD;
             palbociclib with hormonal therapy.&#xD;
&#xD;
          -  Castrate resistant adenocarcinoma of the prostate: PD on enzalutamide monotherapy.&#xD;
&#xD;
          -  Castrate resistant adenocarcinoma of the prostate: PD on abiraterone in combination&#xD;
             with prednisone.&#xD;
&#xD;
          -  germline mutated BRCA (gBRCAm), HER2- breast cancer: PD on a PARP inhibitor&#xD;
             monotherapy in patients previously treated with chemotherapy in the neoadjuvant,&#xD;
             adjuvant, or metastatic setting.&#xD;
&#xD;
          -  Radiographic evidence of PD, including the target lesion being subjected to biopsy for&#xD;
             the study, on the most recent regimen that requires a change in anti-cancer treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Tumor biopsy taken from a bone or an irradiated target lesion.&#xD;
&#xD;
          -  Discontinuation of current or most recent anti cancer therapy due to toxicity and not&#xD;
             progressive disease.&#xD;
&#xD;
          -  Initiation of new anti-cancer therapy after disease progression prior to planned&#xD;
             biopsy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Southern Cancer Center, P.C.</name>
      <address>
        <city>Daphne</city>
        <state>Alabama</state>
        <zip>36526</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Cancer Center, PC</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Cancer Center, PC</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alaska Urological Institute dba Alaska Clinical Research Center</name>
      <address>
        <city>Anchorage</city>
        <state>Alaska</state>
        <zip>99503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arizona Oncology Associates, PC-HOPE</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arizona Oncology Associates, PC - HOPE</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85711</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Oncology Institute of Hope Innovation</name>
      <address>
        <city>Glendale</city>
        <state>California</state>
        <zip>91204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Oncology Institute of Hope Innovation</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCI Medical Center-Chao Family Comprehensive Cancer Center</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868-3201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Oncology Institute of Hope Innovation</name>
      <address>
        <city>Santa Ana</city>
        <state>California</state>
        <zip>92705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sansum Clinic</name>
      <address>
        <city>Santa Barbara</city>
        <state>California</state>
        <zip>93105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sansum Clinic</name>
      <address>
        <city>Solvang</city>
        <state>California</state>
        <zip>93463</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Oncology Institute of Hope and Innovation</name>
      <address>
        <city>Whittier</city>
        <state>California</state>
        <zip>90602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ICRI-Administrative and Supplies Only</name>
      <address>
        <city>Whittier</city>
        <state>California</state>
        <zip>90603</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Woodlands Medical Specialists PA</name>
      <address>
        <city>Pensacola</city>
        <state>Florida</state>
        <zip>32503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Cancer Care Alliance</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clínica Viedma S.A.</name>
      <address>
        <city>Viedma</city>
        <state>RIO Negro</state>
        <zip>8500</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanatorio de la Mujer</name>
      <address>
        <city>Rosario</city>
        <state>Santa FÉ</state>
        <zip>S2000ORE</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Britanico de Buenos Aires</name>
      <address>
        <city>Caba</city>
        <zip>C1280AEB</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Educacion Medica e Investigaciones Clinicas&quot;Norberto Quirno&quot; CEMIC</name>
      <address>
        <city>Ciudad Autónoma de Bs As</city>
        <zip>C1431FWO</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grand Hôpital de Charleroi - Site Notre Dame</name>
      <address>
        <city>Charleroi</city>
        <zip>6000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Maria Middelares</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Gent</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital de Jolimont</name>
      <address>
        <city>Haine-Saint-Paul</city>
        <zip>7100</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Saint-Pierre Ottignies</name>
      <address>
        <city>Ottignies</city>
        <zip>1340</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Jean Perrin</name>
      <address>
        <city>Clermont Ferrand</city>
        <zip>63011</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpitaux Civils de Colmar, Centre Hospitalier Louis Pasteur</name>
      <address>
        <city>Colmar</city>
        <zip>68024</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Henri Mondor</name>
      <address>
        <city>Créteil</city>
        <zip>94010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital La Croix du Sud</name>
      <address>
        <city>Quint Fonsegrives</city>
        <zip>31130</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Jean Godinot</name>
      <address>
        <city>Reims Cedex</city>
        <zip>51056</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Bégin</name>
      <address>
        <city>Saint-Mande</city>
        <zip>94160</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Cornwall Hospital</name>
      <address>
        <city>Cornwall</city>
        <zip>TR1 3IJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Belgium</country>
    <country>France</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Austria</country>
    <country>Germany</country>
    <country>Spain</country>
  </removed_countries>
  <link>
    <url>https://pmiform.com/clinical-trial-info-request?StudyID=A9001502</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>May 12, 2021</last_update_submitted>
  <last_update_submitted_qc>May 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Non Small Cell Lung Cancer</keyword>
  <keyword>Renal Cell Carcinoma</keyword>
  <keyword>HR+ HER2- Breast Cancer</keyword>
  <keyword>Castrate-Resistant Prostate Cancer</keyword>
  <keyword>Germline mutated BRCA, HER2- Breast Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Disease Progression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
    <ipd_url>https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests</ipd_url>
  </patient_data>
  <pending_results>
    <submitted>November 29, 2021</submitted>
    <returned>February 23, 2022</returned>
    <submitted>April 12, 2022</submitted>
    <returned>January 11, 2023</returned>
    <submitted>February 4, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04436120
org study id: A9001502
secondary id: TRANSLATE
secondary id: 2018-003612-45
nct id: NCT04436120
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The TRANSLATE study aims to better understand why tumors become resistant to standard
      anti-cancer therapies.

      New tumor biopsy and blood samples are collected after disease progression on
      standard-of-care anti-cancer treatment and compared to the initial (archival) tumor biopsy
      sample taken from the same patient.

      Annotated reports of results from clinical Next Generation Sequencing (NGS) gene panel tests
      of both tumor and blood are sent directly from the testing lab to the study physician for
      discussion with the patient during the study.

      Patients may participate in interventional treatment clinical trials at the same time as
      participating in the TRANSLATE study.

      Primary data will be publicly available after the study to support further research.
Background: Development of new cancer treatments requires better understanding of why tumors
      develop resistance to standard-of-care (SOC) therapies. However, post-progression tumor
      biopsies are not routinely collected, limiting the tissue available to characterize
      mechanisms of treatment resistance. The TRANSLATE clinical study is specifically designed to
      address these critical gaps.

      Trial design: TRANSLATE is a global, multicenter, translational study designed to collect and
      compare archival pre-treatment tumor tissue with paired de novo tumor and blood samples
      obtained following disease progression on SOC therapies, targeting therapeutically important
      areas of cancer biology.

      Eligible Tumor Type and Most Recent SOC Therapy:

        -  Non-small-cell lung and Anti-PD-1/-L1 monotherapy

        -  Non-small-cell lung and Anti-PD-1/-L1 + platinum

        -  Clear cell renal cell carcinoma and Anti-PD-1/-L1 monotherapy

        -  Clear cell renal cell carcinoma and Doublet anti-PD-1/-L1 + anti-CTLA-4

        -  Clear cell renal cell carcinoma and Pembrolizumab + axitinib

        -  Clear cell renal cell carcinoma and Avelumab + axitinib

        -  HR+ HER2- breast and Palbociclib + hormonal therapy

        -  germline mutated BRCA breast and Olaparib or talazoparib monotherapy

        -  Castration-resistant prostate and Enzalutamide

        -  Castration-resistant prostate and Abiraterone + prednisone

      Eligibility criteria include adults with locally advanced or metastatic tumors; radiographic
      evidence of progressive disease during the most recent SOC regimen; sufficient archival tumor
      tissue; and a post-progression tumor lesion that is safely accessible for a new biopsy.

      The results from clinical NGS panel testing may help inform subsequent treatment plan or
      identification of relevant interventional clinical trials.

      Patients are enrolled after disease progression on SOC and before change in treatment and
      participate in 3 study visits within approximately 3 months.

      Next-generation sequencing results from analysis of tumor tissue and blood will be returned
      to the study physician and patient for review at a subsequent study visit within this
      timeframe.

      The primary endpoint is the change in frequency of gene alterations between pre-treatment and
      post-progression tumor biopsies. Secondary endpoints address prioritized scientific
      hypotheses specific to each target area of biology and indication.

      Primary data will be publicly available after the study to support further research.

      Sponsored by Pfizer Inc.; EudraCT: 2018-003612-45.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change in the frequency of gene alterations between pre treatment tumor samples and post progression tumor biopsies
time frame: Through study completion, approximately 3 months
measure: Proportion of patients with fully evaluable archival and post progression tumor biopsy (eg, sample sufficient for all intended analyses at all measured time points)
time frame: Through study completion, approximately 3 months
measure: Concordance of gene alterations between post progression biopsy tissue and blood NGS results
time frame: Through study completion, approximately 3 months
measure: Change in the frequency of alterations in genes encoding HLA, Beta-2 Microglobulin, STAT1, JAK1, JAK2, IFN-gamma and IFN- gamma R between pre treatment archival and post progression samples
time frame: Through study completion, approximately 3 months
measure: Frequency of alterations in genes encoding HLA, Beta 2 Microglobulin, STAT1, JAK1, JAK2, IFN-gamma and IFNGR in cfDNA
time frame: Through study completion, approximately 3 months
measure: Change in the frequency of RB1 gene alterations between pre treatment archival and post progression samples
time frame: Through study completion, approximately 3 months
measure: Frequency of RB1 gene alterations in cfDNA
time frame: Through study completion, approximately 3 months
measure: Change in the frequency of AR gene alterations between pre treatment archival and post progression samples
time frame: Through study completion, approximately 3 months
measure: Frequency of AR gene alterations in cfDNA
time frame: Through study completion, approximately 3 months
measure: Changes in the expression of nuclear hormone receptors or related RNA signatures reflecting nuclear receptor pathway activity between pre treatment archival and post progression samples
time frame: Through study completion, approximately 3 months
measure: Change in the frequency of somatic reversion alterations in gBRCA mutant allele between pre treatment archival and post progression samples
time frame: Through study completion, approximately 3 months
arm group label: Tumor biopsy and blood draw
arm group type: Other
description: Tumor biopsy and blood draw
intervention type: Procedure
intervention name: De novo tumor tissue biopsy
description: De novo tissue biopsy performed following disease progression
arm group label: Tumor biopsy and blood draw
intervention type: Procedure
intervention name: Research blood draws
description: Blood biospecimens collected following disease progression
arm group label: Tumor biopsy and blood draw
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
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country: Argentina
country: Belgium
country: France
country: United Kingdom
country: United States
country: Austria
country: Germany
country: Spain
url: https://pmiform.com/clinical-trial-info-request?StudyID=A9001502
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Disease Progression
sharing ipd: Yes
ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
ipd url: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
submitted: November 29, 2021
returned: February 23, 2022
submitted: April 12, 2022
returned: January 11, 2023
submitted: February 4, 2023