Oncology Areas of Interest

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 Investigator Sponsored Research with binimetinib from US, Canada, Latin America, Africa and the Middle East. Organizations interested in sponsoring research studies in South Korea or Japan should apply to Ono Pharmaceutical Co. Ltd. Organizations interested in sponsoring research in Israel should apply to Medison. Organizations interested in sponsoring research in all other geographies not noted above should apply to Pierre Fabre. 

BRAF V600E/K mutant melanoma (in combination with encorafenib):

• studies incorporating real world data on real world use including: treatment patterns and outcomes, factors for treatment choices, sub-populations, and unmet needs under the current treatment landscape
• molecular characterization of response/resistance to BRAF inhibition in melanoma

Out of scope

• studies in adjuvant setting 
• combinations with immuno-oncology agents
• binimetinib as a single agent
• alternative routes of administration
• studies targeting NRAS mutations

Real World Data analyses:

• Treatment-Free Remission
• 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
• Exploration of different interventions / instruments to improve patient adherence and assess quality of life

Frontline classical Hodgkin Lymphoma (cHL) or peripheral T-cell lymphoma (PTCL)

• Treatment adapted approaches for optimization including adverse event (AE) management
• Characterization and management of Adverse Events (AEs)
• Real world management

Diffuse large B-cell lymphoma (DLBCL)

• Treatment patterns inclusive of post-polatuzumab vedotin, chimeric antigen receptor T cell therapy (CAR-T), and/or bispecifics 
• Burden of illness
• Novel combinations

Unique Populations

• Novel combinations in patients with rare CD30+ expressing tumors
• Treatment patterns
• Burden of illness

Biomarkers

• Effects of BV on the immune system
• CD30 expression on different immune subsets
• Improvement of CD30 detection
• Biomarker strategies to identify patients at risk for peripheral neuropathy

Out of Scope

• Combinations with unapproved agents
• Relapse/refractory cHL, PTCL or cutaneous T-cell lymphoma (CTCL)
• Anaplastic large cell lymphoma (ALCL)
• Follicular lymphoma (FL)
• Marginal zone lymphoma (MZL)
• Mantle cell lymphoma (MCL)
• Frontline diffuse large B-cell lymphoma (DLBCL)

To apply for Investigator Sponsored Research outside the US and Canada, please visit the Takeda Investigator-Sponsored Research portal.

ROS1 positive NSCLC

Generate retrospective Real-World Data (RWD) to evaluate:

• Long-term outcomes, including overall survival (OS)
• Crizotinib in first-line
• Subsequent treatments

Out of Scope:

• Establishing and validating new ALK, ROS or MET testing methods
• Adjuvant NSCLC
• Anaplastic large cell lymphoma (ALCL), IMT (inflammatory anaplastic lymphoma kinase [ALK]-positive myofibroblastic tumors) and pediatric studies
• Immunotherapy combinations
• ROS1 driven tumors (excluding NSCLC)
• ALK and MET driven tumors

Metastatic Non-Small Cell Lung Cancer (mNSCLC)

• Real world evidence (RWE) 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)

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

• Relapsed-Refractory Multiple Myeloma (MM)
  • Characterization and management of Adverse Events 
  • Tailored treatment in patient subpopulations based on age/fitness/comorbidities
  • Response- and risk-adapted approach
  • Investigation and intervention against resistance/relapse
• Newly Diagnosed MM
  • Frontline use in Transplant-Ineligible/Transplant-Eligible including Autologous Stem-Cell Transplant (ASCT)/Chimeric Antigen Receptor T-cells (CAR-T) sequencing
  • Validation of earlier efficacy surrogates
  • Assessment of burden of toxicity and outcomes of mitigation strategy
  • Contribution to patient- and disease-specific frontline segmentation
• Sequence/Combine with Novel Agents or Standard of Care Across MM Lines of Treatment
  • Combination with novel agents with a focus on immuno-oncology 
  • Sequencing approaches
  • Retreatment-rechallenging strategies
• Within and Beyond Plasma Cell Dyscrasias 
  • Extramedullary Disease
  • Plasma-Cell Leukemia
  • Waldenstrom Macroglobulinemia and other Lymphoproliferative diseases

Pfizer is accepting proposals for Investigator Sponsored Research with encorafenib from US, Canada Latin America, Africa and the Middle East. Organizations interested in sponsoring research studies in South Korea or Japan should apply to Ono Pharmaceutical Co. Ltd. Organizations interested in sponsoring research in Israel should apply to Medison. Organizations interested in sponsoring research in all other geographies not noted above should apply to Pierre Fabre.

BRAF V600E/K mutant unresectable or metastatic melanoma (in combination with binimetinib):

• studies incorporating real world data on real world use including: treatment patterns and outcomes, factors for treatment choices, sub-populations, and unmet needs under the current treatment landscape
• molecular characterization of response/resistance to BRAF inhibition in melanoma

Out of scope

• studies in adjuvant setting
• combinations with immuno-oncology agents
• encorafenib as a single agent
• alternative routes of administration
• studies targeting NRAS mutations

BRAF V600E mutant metastatic colorectal cancer (CRC):

• treatment sequencing strategies
• molecular responses to encorafenib (e.g., ctDNA, molecular profile)
• studies incorporating real world data on real world use including: treatment patterns, outcomes and unmet needs under the current treatment landscape 
• studies addressing encorafenib resistance (e.g., re-challenge, novel rational combinations)
• neoadjuvant studies
• studies incorporating patient reported outcomes or patient preference

Out of scope

• encorafenib as a single agent
• alternative routes of administration
• Non-V600E BRAF mutant CRC
• tumor-agnostic approaches with encorafenib

To apply for Investigator Sponsored Research in the United States, please visit the Astellas Investigator-Sponsored Research portal.

Muscle Invasive Bladder Cancer, locally advanced/metastatic Urothelial Carcinoma (MIBC, la/mUC)

• Adverse event prevention, treatment and mitigation  
• Retreatment in patients previously exposed to enfortumab vedotin in MIBC, la/mUC 
• Clinical resistance 
• Combinations/sequences with targeted therapies that have evidence of monotherapy activity and safety in the relevant tumor type (la/mUC and MIBC)
• Health economics and outcomes studies evaluating patterns of retreatment in UC

Nectin-4 expressing tumors with scientific rationale

Nectin-4 expression testing is not required for Urothelial Carcinoma (if Nectin-4 testing is desired by investigator for UC, then testing required via separate agreement with Q2 Solutions). For non-UC tumors Nectin-4 expression testing required unless there is sufficient evidence to support Nectin-4 expression in the tumor being studied.

Other tumors include: HR+/HER2- Breast Cancer, Triple Negative Breast Cancer (TNBC), Squamous Non-Small Cell Lung Cancer (SNSCLC), Non-Squamous Non-Small Cell Lung Cancer (NSNSCLC), Head and Neck Cancer and Gastric, Gastroesophageal Junction or Esophageal Cancer. This includes any stage, all tumor associated subtypes and combinations.

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 of role of Inotuzumab in front-line treatment of ALL*

• Studies incorporating comparator to SOC
• Studies expanding on existing evidence

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
• Addressing resistance mechanisms

* InO in combination with highly intensive chemotherapy are out of scope

Non-Small Cell Lung Cancer (NSCLC):

• 1L lorlatinib outcomes in the Real-World setting: effectiveness, safety, quality of life and adherence 
• Effectiveness of proactive and early adverse events management and correlation with patients’ outcomes
• Safety profile in patients with comorbidities (mental illness, cardiovascular disease and obesity)
• Evidence to predict adverse events with lorlatinib including CNS adverse events, hyperlipidemia, cardiovascular risk and weight gain.
• Optimal sequencing after lorlatinib in 1L
• Lorlatinib ALK resistance patterns

Out of Scope:

• establishing and validating new ALK or ROS testing methods
• adjuvant NSCLC
• pediatric studies
• immunotherapy combinations
• 2L ROS1 NSCLC
• Other indications beyond NSCLC

Breast Cancer

Studies that utilize real world data in HR positive HER2 negative metastatic breast cancer (mBC)

• Single arm palbociclib studies describing clinical outcomes and key subgroups
• Clinical characterization (i.e. comorbid conditions) and concomitant medications of patients in first-line setting 
• Studies employing innovative technology/Artificial Intelligence (AI) to enhance the quality and credibility of real-world data sources and analyses
• General methodologic studies to foster a greater understanding of the credibility of real-world evidence (RWE)

Out of Scope

• All other tumor types beyond mBC
• Studies examining palbociclib in combination with novel treatments
   

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

NOTE: only proposals from China will be considered

Lung Cancer:

• Sugemalimab mechanism of action (antibody-dependent cellular phagocytosis, etc.)
• Non-Small Cell Lung Cancer (NSCLC) neoadjuvant therapy
• Unresectable locally-advanced NSCLC therapy
• Advanced NSCLC immunotherapy real world evidence
• Small-Cell lung cancer therapy
• Immunotherapy combinations in lung cancer
• Special population therapy
• Late-line therapy after targeted therapy or previous immunotherapy failure
• Immunotherapy biomarker and microenvironment
• NSCLC adjuvant therapy

Out of Scope:

• Establishing PD-L1 testing methods
• Pediatric studies

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

Out of Scope:

• Breast cancer, pediatric studies, hematology, rare tumors, pancreatic cancer, single agent in Non-Small Cell Lung Cancer (NSCLC) and ovarian cancer
• Combinations with chemotherapy (except temozolomide)
• Combinations with immune checkpoint inhibitors

Cervical Cancer

• Adverse event management for patients treated with tisotumab vedotin
• Combinations with approved agents without known or suspected drug - drug interactions
• Sequencing studies
• Prospective Real-World studies
• Specific patient populations

Proof of Concept and Non-cervical cancers

• Locally advanced disease settings including combination with treatments of curative intent (e.g. Neo/adjuvant with surgery, combination, or sequencing with chemoradiation therapy)
• Specific treatment settings utilizing combination or sequencing approach (e.g. post-immuno-oncology agent)
• Retreatment and resistance mechanisms in patient treated with tisotumab vedotin)
• Other solid tumors with known tissue factor (TF) expression

Preclinical

• Change in TF expression following exposure to treatments
• TF expression in other solid tumors
• Translational research to understand impact of tumor microenvironment related to TF expression, activity, and toxicity of tisotumab vedotin

Out of Scope:

• Pediatric neuroblastoma
• Osteosarcoma
• Central Nervous System disease (CNS)
• High grade gliomas/glioblastomas (HGG/GBM)
• Medulloblastoma (MB)
• Diffuse intrinsic pontine glioma (DIPG)

To apply for Investigator Sponsored Research in Japan, please visit the Genmab Investigator-Sponsored Research portal.

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

Breast cancer

• Non-interventional sequencing studies involving tucatinib-based therapy following prior T-DXd in HER2+ mBC
• Delay and/or prevention of CNS metastases with tucatinib-based therapy in HER2+ mBC
• Treatment de-escalation, maintenance or switch approaches involving tucatinib-based therapy in HER2+ mBC
• Treatment and adverse event management for patients treated with tucatinib-based therapy
• Re-induction or treatment beyond progression following prior tucatinib-based treatment

Colorectal cancer and other solid tumors (non-breast)

• HER2+ or HER2 mutated tumors
• Novel adjuvant and neoadjuvant combinations
• Novel Metastatic combination regimens for retreatment or treatment beyond progression following prior tucatinib based treatment
• Combinations with novel agents without known or suspected drug-drug interactions or other therapeutic modalities
• Prospective RWE/Quality of Life (QoL) studies for tucatinib + trastuzumab