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

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

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 or bispecific antibodies
• Relapsed/refractory cHL, PTCL including Anaplastic large cell lymphoma (ALCL), or cutaneous T-cell lymphoma (CTCL)
• 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.

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 (RRMM)

• Effectiveness and safety outcomes
• Sequencing optimization
• Combination strategies with other treatment agents

Newly Diagnosed Multiple Myeloma (NDMM)

• Optimal use in induction treatment
• Consolidation strategies post-induction
• Tailored regimens for unfit/frail patients
• Combination with standard-of-care treatments and novel agents

Priorities Across MM Lines of Treatment

• Optimizing treatment duration and dosing
• Outpatient and at-home administration
• Monitoring and mitigation of infections, CRS, ICANS, and viral reactivation
• Response and progression markers

Within and Beyond Plasma Cell Dyscrasias

• Extramedullary Disease
• Plasma-Cell Leukemia
• Waldenstrom Macroglobulinemia, other Lymphoproliferative diseases, and plasma cell dyscrasias.

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

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

ALK+ Non-Small Cell Lung Cancer (ALK+ NSCLC):

• 1L lorlatinib outcomes in the real-world setting: effectiveness, safety, patient-reported outcomes 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 in 1L
• Predictive factors for early progression and treatment intensification strategies with lorlatinib in 1L therapy

Out of Scope

• Establishing and validating new ALK or ROS1 testing methods
• Adjuvant NSCLC
• 2L ROS1+ NSCLC
• Other indications beyond NSCLC

Pfizer will give priority to investigator-sponsored research proposals that focus on genitourinary tumors (prioritizing urothelial cancer).

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

- Evaluation of anti-PD-1 imAE monitoring and therapy management in HR-NMIBC
- Additional subgroup data of Sasanlimab in combination with BCG in BCG naïve HR NMIBC
- Patient populations or treatment schedules not investigated in CREST
- Biomarker to inform response, resistance and treatment decisions in NMIBC

Preclinical or translational research studies exploring IB6:

• Prevalence of Integrin beta-6 (IB6) expression, overall and in specific tumor types (non-small cell lung cancer, head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, esophageal adenocarcinoma, breast cancer, pediatric tumors, etc.)
• Population differences, if any, of IB6 expression (e.g. Asia Pacific vs United States vs Europe, smokers vs nonsmokers, age, etc.)
• IB6 expression patterns throughout course of disease (local vs metastatic, primary vs distant metastases)
• Role of IB6 in oncogenesis
• Association of IB6 expression and disease prognosis

 Preclinical research studies exploring sigvotatug vedotin (SV):  

• Exploration of SV’s preclinical antitumor activity in relevant tumor models, including pediatric
• Investigation of potential immune modulatory effects of SV in preclinical tumor models

 Out of Scope: Clinical/Interventional research proposals

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

Metastatic Prostate Cancer:

• Studies that help inform optimal/most appropriate use of talazoparib in combination with enzalutamide
• Strategies to delay / overcome resistance to Standard of Care treatments in advanced prostate cancer
• Therapy management for the combination of talazoparib + enzalutamide
• Studies that inform optimal sequencing of available therapies in relation to the combination of talazoparib and enzalutamide

Non-metastatic Prostate Cancer:  In exceptional circumstances with accompanying supportive data.

Out of Scope:

• Pediatric Studies
• All tumor types except prostate cancer, including but not limited to:
  • Hematology
  • Rare tumors
  • Breast cancer
  • Pancreatic tumors
  • NSCLC
  • Ovarian cancer
• Combinations with chemotherapy, 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 Europe or Japan, please visit the Genmab Investigator-Sponsored Research portal.

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