Sorry, you need to enable JavaScript to visit this website.

Oncology Areas of Interest

IMPORTANT: The Oncology ISR Program has implemented application windows for unsolicited requests. Please click here to view the Quarterly Application and Review Cycles.

Qualified researchers are invited to submit investigator-sponsored research (ISR) proposals, according to the guidance and instructions found on the Pfizer ISR portal at www.Pfizer.com/ISR. All proposals must be submitted via the ISR submission portal. An ISR proposal requesting Pfizer support (e.g., funding and/or drug supply) is not a guarantee of acceptance or approval of that proposal. Decisions on support for ISR submissions are made by the applicable Pfizer Global Review Committee. A formal notification regarding the status of your application will be sent once a decision is reached. Pfizer support will only be extended upon the execution of an ISR agreement. For any questions, please send an email to [email protected].

Oncology compounds are listed below alphabetically. For each compound, the areas of interest are listed in order of medical and scientific unmet need.

  • Merck KGaA, Darmstadt, Germany, and Pfizer Inc formed a strategic alliance to develop and commercialize Merck KGaA’s anti-PD-L1 asset known as avelumab.

    The Alliance will give priority to investigator-sponsored research proposals that focus on genitourinary tumors (prioritizing renal cell carcinoma and urothelial cancer).

    In addition, investigator-sponsored research proposals that focus on the following themes may be considered:

    • Safety and efficacy of novel combinations with avelumab and/or sequencing based on strong scientific rationale and/or developing trends in the field (monotherapy trials will be de-prioritized)
    • Further understanding of the clinical usefulness of engaging the innate immune system with avelumab
    • Duration of therapy evaluations
    • Identification of other biomarkers or biomarker-defined subgroups e.g. long-term responders
    • Consider continuing to support studies that have demonstrated proof of concept
    • Understanding of primary, adaptive, and/or acquired resistance to IO therapy

    Please note: Any proposal involving combination with another Pfizer asset should be submitted via the Pfizer portal and any proposal involving combination with another Merck KGaA asset should be submitted via its company portals (www.ist.emdserono.com for U.S. & Canada, and www.iss.merckbiopharma.com for all other countries).

  • Metastatic Renal Cell Carcinoma (RCC)

    • First Line (1L) Immuno-oncology (IO) combinations with supporting evidence
    • Efficacy/Safety for combinations with IO post-1L
    • Efficacy/Safety for sequencing post-1L
    • TKI+IO mechanistic data
    • Real World Data (RWD) studies

    Non-RCC: Areas of high unmet medical need with strong evidence supporting the use of anti-angiogenic therapies alone or in combination

  • Proposals for interventional, non-interventional, basic science, or other studies that:

    • Demonstrate the value or economic benefit of the biosimilar
    • Incorporate Real World Data and/or Patient Reported Outcomes
    • Evaluate the integration of the biosimilar with a standard-of-care regimen in an approved indication not previously evaluated
    • Explore rational treatment combinations with other Pfizer medicines

    Out of Scope:

    • Head-to-Head Comparative clinical trials of the biosimilar versus the originator drug
    • Studies in a country in which the biosimilar has not received regulatory approval
    • Country in which commercial supply of the biosimilar is not available (there may be very limited exceptions)
    • Pediatric Trials
  • Pfizer is accepting proposals for independently sponsored research with binimetinib from US and Canadian investigators in the following research areas. Investigators interested in sponsoring research studies in South Korea or Japan should apply to Ono Pharmaceutical Co. Ltd. Investigators interested in sponsoring research in Israel should apply to Medison. Investigators interested in sponsoring research in all other geographies not noted above should apply to Pierre Fabre.

    BRAF mutant melanoma:

    In combination with encorafenib,

    • adjuvant treatment
    • rational combinations to overcome MAPK pathway treatment resistance
    • immunotherapy combination treatment
    • studies that utilize biomarker informed treatment
    • sequencing and retreatment strategies

    BRAF mutant colorectal cancer:

    • rational combinations with encorafenib and cetuximab and/or other agents to overcome MAPK pathway resistance
    • immunotherapy combination treatment
    • studies that utilize biomarker informed treatment
    • sequencing and retreatment strategies

    Other malignancies:

    • combination with encorafenib in BRAF driven mutations
    • novel combinations with other agents when supported by preclinical data

    Studies incorporating real world data (RWD) or patient reported outcomes (PRO)

    Out of scope: binimetinib monotherapy studies

    • Treatment-Free Remission
      • Retrospective analyses utilizing registries / Real World Data (RWD)
      • Pragmatic time-efficient design for prospective studies
    • Real World Data analyses:
      • Incidence of and risk factors for Adverse Events (AEs) of Special Interest (e.g. Cardiovascular AEs) in Real World
      • Management of common and long-term adverse events including dose modification / individualization
      • Optimal sequencing or switching combinations with other Tyrosine Kinase Inhibitors (TKIs)
      • Exploration of different interventions / instruments to improve patient adherence
    • Translational research in human tissues as add-on studies to ongoing clinical trials:
      • Biomarker studies to identify or predict response, resistance, toxicity
      • Biomarker studies to investigate mechanism of toxicities
  • ROS1 positive NSCLC  
    •    Collecting long term outcomes from Real World Data (RWD)


    Out of Scope
    •    Establishing and validating new ALK, ROS or MET testing methods
    •    Adjuvant NSCLC
    •    Anaplastic Large Cell Lymphoma (ALCL)
    •    Pediatric studies
    •    Immunotherapy combinations
    •    ALK driven tumors
    •    MET driven tumors 
    •    ROS1 driven tumors (excluding NSCLC)
     

  • Metastatic Non-Small Cell Lung Cancer (mNSCLC) 
    •    Real world data (RWD) studies in first-line (1L) EGFR mutant mNSCLC including studies focused on EGFR exon 21 L858R mutations from Latin America, Africa, Middle East, and Asian countries (except Japan)
    •    Combination therapy in 1L EGFR mutant mNSCLC, including with VEGF targeted agents

    Out of Scope
    •    Unselected NSCLC
    •    HER2 NSCLC and other HER2 driven tumors
    •    Post-EGFR TKI use including post osimertinib
    •    Immunotherapy combinations
    •    Establishing and validating new EGFR testing methods
    •    EGFR driven tumors (excluding NSCLC)
    •    Adjuvant setting
     

    • Advanced multiple myeloma and basic science
      • Dosing and administration optimization including Health-Related Quality of Life (HRQoL) and Patient Reported Outcomes (PRO) studies
      • Preclinical studies (biomarkers and mechanisms of high or reduced response to elranatamab; predictors of elranatamab associated toxicities, explore drug combinations)
    • Earlier lines of multiple myeloma therapy
      • Newly Diagnosed Multiple Myeloma (NDMM) or 1st relapse Relapsed Refractory Multiple Myeloma (RRMM)
      • Combinations/sequence with novel agents or standard of care therapy
      • Minimal Residual Disease (MRD) directed/guided treatment strategies
      • Consolidation and/or maintenance therapy
      • Populations of high unmet need underserved by current SOC
    • Malignancies targetable by BCMA directed therapy
      • AL Amyloidosis
      • High-risk smoldering myeloma
      • Solitary plasmacytoma
  • Pfizer is accepting proposals for independently sponsored research with encorafenib from US and Canadian investigators in the following research areas. Investigators interested in sponsoring research studies in South Korea or Japan should apply to Ono Pharmaceutical Co. Ltd. Investigators interested in sponsoring research in Israel should apply to Medison. Investigators interested in sponsoring research in all other geographies not noted above should apply to Pierre Fabre.

    BRAF mutant melanoma:

    In combination with binimetinib,

    • adjuvant treatment
    • rational combinations to overcome MAPK pathway treatment resistance
    • immunotherapy combination treatment
    • studies that utilize biomarker informed treatment
    • sequencing and retreatment strategies

    BRAF mutant colorectal cancer:

    • combination with binimetinib
    • combinations with cetuximab +/- binimetinib in selected patient populations
    • combinations with cetuximab +/- binimetinib and/or novel agents to overcome MAPK pathway resistance
    • studies that utilize biomarker informed treatment

    Other BRAF malignancies:

    • combination with binimetinib
    • novel combinations with other agents when supported by preclinical data

    Studies incorporating real world data (RWD) or patient reported outcomes (PRO)

    Out of scope:

    encorafenib monotherapy studies

  • Astellas and Pfizer jointly develop enzalutamide and jointly commercialize it in the United States. IIR proposals are currently accepted from the United States only through the Astellas portal at www.globalisrportal.force.com. Questions regarding the Astellas process may be sent to [email protected]

    Prostate Cancer

    • New approaches for treatment of prostate cancer, including drug and non-drug (modality) combinations
    • Research in early stages of prostate cancer
    • Adverse event management under standard enzalutamide dosing
    • Biomarkers to inform response, resistance and treatment decisions
    • Patient reported outcomes and quality of life in Prostate Cancer
    • New screening, artificial intelligence, & diagnosis technology in conjunction with Prostate Cancer treatment
    • Understanding mechanisms of androgen receptor inhibitor action and resistance
    • Treatment of oligometastatic disease

    Out of Scope:

    All tumor types other than prostate cancer

  • Improving outcomes of newly diagnosed Acute Myeloid Leukemia (AML) patients in combination with standard chemotherapy:

    • Studies supporting therapy management risk factors, susceptibility and mechanism of VOD and other common AEs
    • Treatment patterns, diagnosis and risk stratification correlated with outcomes
    • Sequencing/combination with novel agents
    • Patient-reported outcomes, health-related quality of life and innovative uses of big data
  • Exploration in relapsed/refractory Acute Lymphocytic Leukemia (ALL):

    • Real World Data (RWD) exploring efficacy / safety or Health Economics and Outcomes Research in different subset populations
    • Pre- and Post-CART
    • Studies supporting therapy management and dose optimization
    • Biomarkers and early detection of response
    • Further defining efficacy in CNS (for example RANO criteria)
    • Validating therapy management techniques
    • Collecting RWD on lorlatinib outcomes in second-line (2L) treatment post-alectinib or brigatinib
    • Expanding the lorlatinib dataset for 2L ROS1+ NSCLC
    • Defining lorlatinib ALK and ROS resistance patterns
    • Rational combinations to treat or prevent lorlatinib resistance

    Out of Scope:

    Establishing and validating new ALK, ROS or MET testing methods, adjuvant NSCLC, Anaplastic Large Cell Lymphoma (ALCL), pediatric studies, immunotherapy combinations

  • Breast Cancer

    • Novel treatment strategies to overcome resistance following initial treatment with a CDK4/6 inhibitor + endocrine therapy
    • Studies that utilize Real World Data (RWD)
    • Studies that utilize Patient Reported Outcomes (PRO)

    Out of scope:

    all other tumor types beyond breast cancer

  • Proposals for interventional, non-interventional, basic science, or other studies that:

    • Explore incorporating the biosimilar into a novel combination treatment, existing combination treatment in a novel sequential therapy or novel exploratory end-points within label indications.
    • Explore treatment optimization within a labelled indication
    • Value-Based modeling evaluating the impact of medical quality improvements to prevent acute life-threatening conditions such as infections and atrial fibrillation in CLL, DLBCL and/or FL patients treated with rituximab biosimilars
    • Studies improving outcomes in geriatric oncology patients who are eligible for rituximab or supportive care
    • Studies improving hospital processes to prevent infections in high risk oncology patients who are treated with biosimilars (supportive care and rituximab)
    • Studies evaluating switching rituximab biosimilars

    Out of Scope:

    • Head-to-Head Comparative clinical trials of the biosimilar versus the originator drug
    • Analytical characterization of the rituximab biosimilar
    • Pediatric Trials
  • Urothelial Carcinoma

    • Safety and efficacy of combinations with sasanlimab and/or sequencing based on strong scientific rationale and/or developing trends in the field of Non-Muscle Invasive Bladder Cancer (NMIBC)
    • Validation of anti-PD-1 and/or Standard of Care therapy management techniques in NMIBC
    • Collection of Real-World Data (RWD) experience in NMIBC
    • Safety and efficacy of innovative combinations with sasanlimab in NMIBC and/or neoadjuvant/adjuvant Muscle Invasive Bladder Cancer (MIBC) and bladder sparing approaches
    • Assessment of biomarkers to inform response, resistance, and treatment decisions in NMIBC
  • Metastatic Renal Cell Carcinoma (RCC)

    • Efficacy/Safety for sequencing pre- and post-Immuno-Oncology (IO)
    • Patient selection strategies in First Line (1L)
    • Real World Data (RWD) studies

    Out of scope:

    all other tumor types

  • Prostate Cancer

    • Combination treatment in metastatic Castration Resistant Prostate Cancer (CRPC) and metastatic Castration Sensitive Prostate Cancer (CSPC), particularly novel innovative combination approaches including radiotherapy and targeted agents
    • Strategies to prevent/overcome resistance
    • Therapy management studies for talazoparib combinations

    Breast Cancer

    • Use in maintenance setting
    • Sequencing, long responders and/or therapy management including Real World Data (RWD) sources
    • Efficacy in brain metastases including RWD sources

    Out of Scope:

    • Pediatric studies, hematology, rare tumors, pancreatic cancer, single agent in Non-Small Cell Lung Cancer (NSCLC) and ovarian cancer, neoadjuvant breast cancer, breast cancer beyond germline BRAC alterations
    • Combinations with chemotherapy (except temozolomide)
    • Combinations with immune checkpoint inhibitors
  • Proposals for interventional, non-interventional, basic science, or other studies that:

    • Demonstrate the value or economic benefit of the biosimilar
    • Incorporate Real World Data and/or Patient Reported Outcomes
    • Evaluate the integration of the biosimilar with a standard-of-care regimen in an approved indication not previously evaluated
    • Explore rational treatment combinations with other Pfizer medicines

    Out of Scope:

    • Head-to-Head Comparative clinical trials of the biosimilar versus the originator drug
    • Studies in a country in which the biosimilar has not received regulatory approval
    • Country in which commercial supply of the biosimilar is not available (there may be very limited exceptions)
    • Pediatric Trials