P50CA254865
Project Grant
Overview
Grant Description
Melanoma and Skin Cancer Program SPORE - Project Summary Abstract:
Overall, skin cancers are the most common cancers in the US, including melanoma and cutaneous squamous cell carcinoma (CSCC). Despite substantial progress, most patients with advanced melanoma do not benefit from treatment, while the most potent therapies of melanoma also cause serious adverse events.
In addition, we still need safe, efficient, and cost-effective therapies of CSCCs in immunocompetent and immunodeficient patients that could transform treatment and outcomes for these at-risk patient populations.
The overall goal of the Melanoma and Skin Cancer Program (MSCP SPORE) is to develop novel translational research to overcome the hurdles of current therapies of melanoma and CSCCs. Each of the three projects results from seminal and innovative findings made by the investigators of the MSCP SPORE, which are translated into new combinatorial immunotherapy trials for patients with melanoma and skin cancers.
Project 1 will assess the clinical and immunological activity of anti-LAG3 alone and in combination with anti-PD1, for the first time, in treatment-naïve patients who have not received prior immune checkpoint blockade (ICB).
Project 2 will evaluate the efficacy and immunogenicity of CMP-001 (CMP), a type A CPG, in PD1-naïve metastatic melanoma in the context of a phase II/III randomized clinical trial with intratumoral CMP and nivolumab (CMP/NIVO) vs. nivolumab.
Project 3 will test a novel microneedle array (MNA) device to deliver both a potent chemotherapeutic agent to induce immunogenic cell death and an innate immune stimulant into accessible CSCCs. This approach will be tested both in immunocompetent and immunosuppressed cancer patients.
The MSCP SPORE will use innovative strategies to determine the mechanisms of response and resistance to the proposed therapies. The investigators will be supported by shared-facility cores to provide state-of-the-art expertise and economies-of-scale in:
1) Sample collection and processing, translational pathology, data annotation, biospecimen repository, and immunomonitoring (Core 1).
2) Biostatistics and bioinformatics (Core 2), supporting rigor and reproducibility across all research projects.
The Career Enhancement Program (CEP) and Development Research Program (DRP) will attract talented basic, translational, and clinical investigators into melanoma research.
The MSCP SPORE leverages Hillman Cancer Center (HCC) resources and institutional commitment with state-of-the-art research and clinical facilities, clinical regulatory services to support clinical trial coordination, and translational research.
The MSCP SPORE includes outstanding external and internal advisory boards (EAB, IAB), an executive committee that is highly experienced in the successful management of SPOREs, and patient advocates.
The organizational structure of the MSCP SPORE will facilitate thorough following of progress and managing of potential hurdles for each project.
The MSCP SPORE will share data with the scientific community and other SPOREs in agreement with the NIH policy.
The MSCP SPORE will benefit from and promote a large number of horizontal and vertical collaborations with academic institutions, NCI, pharmaceutical companies, and cooperative groups.
Overall, skin cancers are the most common cancers in the US, including melanoma and cutaneous squamous cell carcinoma (CSCC). Despite substantial progress, most patients with advanced melanoma do not benefit from treatment, while the most potent therapies of melanoma also cause serious adverse events.
In addition, we still need safe, efficient, and cost-effective therapies of CSCCs in immunocompetent and immunodeficient patients that could transform treatment and outcomes for these at-risk patient populations.
The overall goal of the Melanoma and Skin Cancer Program (MSCP SPORE) is to develop novel translational research to overcome the hurdles of current therapies of melanoma and CSCCs. Each of the three projects results from seminal and innovative findings made by the investigators of the MSCP SPORE, which are translated into new combinatorial immunotherapy trials for patients with melanoma and skin cancers.
Project 1 will assess the clinical and immunological activity of anti-LAG3 alone and in combination with anti-PD1, for the first time, in treatment-naïve patients who have not received prior immune checkpoint blockade (ICB).
Project 2 will evaluate the efficacy and immunogenicity of CMP-001 (CMP), a type A CPG, in PD1-naïve metastatic melanoma in the context of a phase II/III randomized clinical trial with intratumoral CMP and nivolumab (CMP/NIVO) vs. nivolumab.
Project 3 will test a novel microneedle array (MNA) device to deliver both a potent chemotherapeutic agent to induce immunogenic cell death and an innate immune stimulant into accessible CSCCs. This approach will be tested both in immunocompetent and immunosuppressed cancer patients.
The MSCP SPORE will use innovative strategies to determine the mechanisms of response and resistance to the proposed therapies. The investigators will be supported by shared-facility cores to provide state-of-the-art expertise and economies-of-scale in:
1) Sample collection and processing, translational pathology, data annotation, biospecimen repository, and immunomonitoring (Core 1).
2) Biostatistics and bioinformatics (Core 2), supporting rigor and reproducibility across all research projects.
The Career Enhancement Program (CEP) and Development Research Program (DRP) will attract talented basic, translational, and clinical investigators into melanoma research.
The MSCP SPORE leverages Hillman Cancer Center (HCC) resources and institutional commitment with state-of-the-art research and clinical facilities, clinical regulatory services to support clinical trial coordination, and translational research.
The MSCP SPORE includes outstanding external and internal advisory boards (EAB, IAB), an executive committee that is highly experienced in the successful management of SPOREs, and patient advocates.
The organizational structure of the MSCP SPORE will facilitate thorough following of progress and managing of potential hurdles for each project.
The MSCP SPORE will share data with the scientific community and other SPOREs in agreement with the NIH policy.
The MSCP SPORE will benefit from and promote a large number of horizontal and vertical collaborations with academic institutions, NCI, pharmaceutical companies, and cooperative groups.
Funding Goals
TO PROVIDE AN ORGANIZATIONAL FOCUS AND STIMULUS FOR THE HIGHEST QUALITY CANCER RESEARCH THAT EFFECTIVELY PROMOTES INTERDISCIPLINARY CANCER RESEARCH AIMED TOWARD THE ULTIMATE GOAL OF REDUCING CANCER INCIDENCE, MORTALITY AND MORBIDITY. THE CANCER CENTER SUPPORT GRANT (CCSG) PROVIDES THE RESOURCES AND INFRASTRUCTURE TO FACILITATE THE COORDINATION OF INTERDISCIPLINARY PROGRAMS ACROSS A BROAD SPECTRUM OF RESEARCH FROM BASIC LABORATORY RESEARCH TO CLINICAL INVESTIGATION TO POPULATION SCIENCE. THE CCSG SUPPORTS SALARIES FOR SCIENTIFIC LEADERSHIP OF THE CENTER, SHARED RESOURCES FOR FUNDED CENTER INVESTIGATORS, CERTAIN ADMINISTRATIVE COSTS, PLANNING AND EVALUATION, AND DEVELOPMENTAL FUNDS FOR NEW RECRUITMENTS AND FEASIBILITY STUDIES.
Grant Program (CFDA)
Awarding / Funding Agency
Place of Performance
Pittsburgh,
Pennsylvania
152133203
United States
Geographic Scope
Single Zip Code
Related Opportunity
Analysis Notes
Amendment Since initial award the total obligations have increased 411% from $2,037,632 to $10,422,245.
University Of Pittsburgh - Of The Commonwealth System Of Higher Education was awarded
Novel Translational Research for Melanoma and Skin Cancer Treatment
Project Grant P50CA254865
worth $10,422,245
from National Cancer Institute in August 2021 with work to be completed primarily in Pittsburgh Pennsylvania United States.
The grant
has a duration of 4 years 10 months and
was awarded through assistance program 93.397 Cancer Centers Support Grants.
The Project Grant was awarded through grant opportunity Specialized Programs of Research Excellence (SPOREs) in Human Cancers for years 2018, 2019 and 2020 (P50).
Status
(Ongoing)
Last Modified 7/21/25
Period of Performance
8/15/21
Start Date
6/30/26
End Date
Funding Split
$10.4M
Federal Obligation
$0.0
Non-Federal Obligation
$10.4M
Total Obligated
Activity Timeline
Subgrant Awards
Disclosed subgrants for P50CA254865
Transaction History
Modifications to P50CA254865
Additional Detail
Award ID FAIN
P50CA254865
SAI Number
P50CA254865-3691275936
Award ID URI
SAI UNAVAILABLE
Awardee Classifications
Other
Awarding Office
75NC00 NIH National Cancer Institute
Funding Office
75NC00 NIH National Cancer Institute
Awardee UEI
MKAGLD59JRL1
Awardee CAGE
1DQV3
Performance District
PA-12
Senators
Robert Casey
John Fetterman
John Fetterman
Budget Funding
| Federal Account | Budget Subfunction | Object Class | Total | Percentage |
|---|---|---|---|---|
| National Cancer Institute, National Institutes of Health, Health and Human Services (075-0849) | Health research and training | Grants, subsidies, and contributions (41.0) | $4,045,014 | 100% |
Modified: 7/21/25