Neoplasms

Digestive System Diseases

All Conditions

Gland and Hormone Related Diseases

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Esophageal Neoplasms

Carcinoma

Cholangiocarcinoma

Pancreatic Neoplasms

Melanoma

Stomach Neoplasms

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Carcinoma, Renal Cell

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Endometrial Neoplasms

Bile Duct Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Head and Neck Neoplasms

Uterine Neoplasms

Uterine Diseases

Biliary Tract Neoplasms

Bile Duct Diseases

Biliary Tract Diseases

Esophageal Cancer

Pancreatic Cancer

Ovarian Cancer

Bile Duct Cancer

Renal Cell Carcinoma

Stomach Cancer

Ovarian Epithelial Cancer

Clear Cell Renal Cell Carcinoma

PF-06940434 is given intravenously (IV) every 2 or 4 weeks in a 28 day cycle or every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated

PF-06940434

PF-06801591 will be administered subcutaneously on Day 1 of each 28 day cycle or Day 1 of each 21 day cycle.

PF-06801591

Pfizer CT.gov Call Center

Open-label, multi-center, non-randomized, multiple dose, safety, tolerability, pharmacokinetic, and pharmacodynamics and clinical activity study of PF-06940434 (Integrin alpha-V/beta-8 Antagonist) in patients with SCCHN (Squamous Cell Carcinoma of the Head and Neck), renal cell carcinoma (RCC - clear cell and papillary), ovarian, gastric, esophageal, esophageal (adeno and squamous), lung squamous cell, pancreatic and biliary duct, endometrial, melanoma and urothelial tumors. This study contains two parts, single agent dose escalation (Part 1A), dose finding of PF 06940434 in combination with anti-PD-1 (Part 1B) and dose expansion (Part 2). Part 2 Dose Combination Expansion will enroll participants into 3 cohorts at doses determined from Part 1B in order to further evaluate the safety of PF-06940434 in combination with anti-PD-1.

Study of PF-06940434 in Patients With Advanced or Metastatic Solid Tumors.

A PHASE 1 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF ESCALATING DOSES OF PF-06940434 IN PATIENTS WITH ADVANCED OR METASTATIC SOLID TUMORS

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.

The period from study entry until disease progression, death or date of last contact.

Maximum observed plasma concentration of PF-06940434.

Time zero extrapolated to the last quantifiable time point prior to the next dose.

CL is a quantitative measure of the rate at which a drug substance is removed from the body.

Titers of neutralizing antibodies (NAb) against PF-06940434.

Maximum observed plasma concentration after multiple doses of PF-06940434 and PD-1 (PF-06801591).

Area under the curve from time zero extrapolated to the last quantifiable dose of PF-06940434 and PF-06801591.

DCR is defined as the percent of participants with a confirmed complete response (CR), partial response (PR) or stable disease (SD) according to RECIST 1.1.

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Incidence and titers of anti-drug antibodies (ADA) against PF-06801591.

Incidence and titers of neutralizing antibodies (NAb) against PF-06801591.

The period from study entry until death or date of last contact (24 months)

Pfizer

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Breast Neoplasms

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Neoplasms, Unknown Primary

Colorectal Neoplasms

Skin Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Male Urogenital Diseases

Neoplasm Metastasis

Neoplastic Processes

Neuroendocrine Tumor

Neuroepithelioma

Advanced breast, non-small cell lung, colorectal, genitourinary, pancreatobiliary gastrointestinal, upper aerodigestive tract, gynecological, melanoma, unknown primary, and rare carcinomas; as well as patients who are phase I trial candidates

Philippe Bedard, MD

Substantial progress has been made in the treatment of cancer through the use of targeted therapies, but what works for one patient might not work for another patient. Certain drugs are now being developed that target specific molecules in the body that are believed to be part of the disease.

Biomarkers are specific characteristics of the cancer that may help provide prognostic information (i.e. how well patients will be regardless of the treatments given) or help predict sensitivity or resistance to a specific treatment.

The study will collect archival tumor samples (previously collected biopsy or surgical tumor samples) to provide biomarker data about a patient's cancer, in order to help their physicians to identify which clinical trials of molecularly targeted therapies may be most appropriate for the patient in the future.

The increasing appreciation and identification of specific somatic mutations and other genetic aberrations that drive cancers leave us on the threshold of a new era of "personalized cancer medicine", in which specific biomarkers will be used to direct targeted agents only to those patients deemed most likely to respond. The potential medical, scientific and economic benefits of such a personalized approach to cancer therapy are immense and self-evident. Yet despite some important advances, only a limited number of approved targeted agents have had their approvals predicated on specific biomarkers of sensitivity or resistance.

The premises behind personalized cancer medicine include: i) genetic aberrations exist in human malignancies; ii) a subset of these aberrations, often present across multiple cancer types, have functional relevance as "hallmarks" or "drivers" for oncogenesis and tumor progression; iii) such genetic aberrations are potentially "druggable" targets; and iv) there are tolerable medicinal compounds that can effectively modulate such targets. A key requirement of this new, personalized approach to anti-cancer therapy is that specific patients must be matched to a particular drug or combination of drugs. Molecular profiling of tumors to identify somatic mutations and/or other genetic aberrations are examples of enrichment strategies to assist in matching patients to drugs or treatments that have gained increasing interest in the oncology community.

The present protocol seeks to provide molecular profiling data to the treating physician for patients with advanced breast, non-small cell lung, colorectal, genitourinary, pancreatobiliary gastrointestinal, upper aerodigestive tract, gynecological, melanoma, unknown primary, and rare carcinomas, as well as patients who are phase I trial candidates, in order to help identify which standard regimens or clinical trials of molecularly targeted therapies may be most appropriate for the individual patient.

Archival tumor tissue

1 tube of whole blood

Integrated Molecular Profiling in Advanced Cancers Trial

Genotyping assays including: AKT1, HRAS, AKT2, JAK2, AKT3, KIT, BRAF, KRAS, CDK, MEK1, CTNNB1, MET, EGFR, NOTCH1, ERBB2, NRAS, FGFR1, PDGFRA, FGFR2, PIK3CA, FGFR3, RET, FGFR4, SMO, STK11

Including utilization of information for standard regimens or clinical trials of molecularly targeted therapies.

Princess Margaret Hospital, Canada

University Health Network, Toronto

Lillian Siu, MD

Bedard Philippe, MD

This is a feasibility study to look for genetic alterations in tissue and blood samples that may be useful in determining what treatments may be useful in the patient's cancer care.

As part of the study, patients will have archival tumor tissue collected, and have tumor biopsies and blood samples taken. The samples will be tested for genetic alterations, and the results will be discussed with the patient including potential treatments. If patients agree, after they have received treatment for their cancer and their disease progresses, a second biopsy procedure will be done.

Feasibility Study of Genomic Profiling Methods and Timing in Tumor Samples

A Feasibility Study of Genomic Profiling Methods and Timing of Sample Collection to Evaluate Clonal Evolution and Tumor Heterogeneity

Sequenom or MiSeq/TSCAP analysis from fresh core needle biopsy samples less than 4 weeks; sequenom or MiSeq/TSCAP analysis from fresh fine needle biopsy samples less than 8 weeks; MiSeq/NGS analysis from fresh core needle biopsy samples less than 8 weeks; MiSeq/NGS analysis from fresh fine needle biopsy samples less than 8 weeks

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of PF-06940434 in Patients With Advanced or Metastatic Solid Tumors.	NCT04152018	Squamous Cell C... Renal Cell Carc... Ovarian Cancer Gastric Cancer Esophageal Canc... Lung Squamous C... Pancreatic Canc... Bile Duct Cance... Endometrial Can... Melanoma Cancer Urothelial Canc...	PF-06940434 PF-06801591	18 Years -	Pfizer
Integrated Molecular Profiling in Advanced Cancers Trial	NCT01505400	Breast Cancer Non-small Cell ... Colorectal Canc... Genitourinary C... Pancreatobiliar... Upper Aerodiges... Gynecological C... Melanoma Cancer... Rare Cancers Unknown Primary...		18 Years -	University Health Network, Toronto
Feasibility Study of Genomic Profiling Methods and Timing in Tumor Samples	NCT01703585	Colorectal Canc... Breast Cancer Gynecological C... Metastatic Eligible for Ph... Melanoma Cancer		18 Years -	University Health Network, Toronto
Study of PF-06940434 in Patients With Advanced or Metastatic Solid Tumors.	NCT04152018	Squamous Cell C... Renal Cell Carc... Ovarian Cancer Gastric Cancer Esophageal Canc... Lung Squamous C... Pancreatic Canc... Bile Duct Cance... Endometrial Can... Melanoma Cancer Urothelial Canc...	PF-06940434 PF-06801591	18 Years -	Pfizer

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