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Ipilimumab plus a galectin-3 inhibitor for metastatic melanoma

Award Number: R21CA190790
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/06/2015
PERIOD OF PERFORMANCE END DATE: 06/30/2018

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Ipilimumab plus a galectin-3 inhibitor for metastatic melanoma - ¿ DESCRIPTION (provided by applicant): Despite recent advances, more effective agents are critically needed for patients with metastatic melanoma. One exciting approach is immunotherapy, which utilizes the patient's immune system to destroy cancer cells. Drugs such as anti-CTLA-4 (ipilimumab) release the "brakes" on specialized white blood cells (T cells) to boost anti-tumor immunity. Unfortunately, monotherapy typically benefits only a subset of patients, which may be due to tumor-induced suppression of the immune response. One way tumors suppress the immune system is by secreting an inhibitory protein, called galectin-3 (Gal-3). Gal-3 enhances tumor growth and metastasis and can also suppress the function of tumor-specific T cells. Given the ability of CTLA-4 and Gal-3 to suppress anti- tumor immunity, the central hypothesis of this proposal is that treatment with a novel Gal-3 inhibitor (GR-MD- 02) plus CTLA-4 blockade (ipilimumab) will enhance tumor regression in patients with advanced melanoma by boosting the function of tumor-specific T cells. This is an innovative approach that targets two unique regulatory pathways to change the tumor microenvironment and enhance T cell activity. Importantly, pre- clinical studies revealed that combined GR-MD-02/anti-CTLA-4 therapy significantly boosted tumor regression and increased the survival of tumor-bearing mice. These data provide a strong rationale for testing the clinical and immunological activity of ipilimumab plus GR-MD-02 in patients with metastatic melanoma. The proposed research is significant because if the immune enhancing and anti-tumor effects from the pre-clinical models are also observed in humans, then clinical care will be considerably enhanced. The objective of this application is to investigate the safety and efficacy of combined GR-MD-02/ipilimumab therapy in a phase I clinical trial and identify the mechanisms by which these agents augment tumor-specific immunity. The goals are to: 1) Determine the safety and efficacy of this novel combination for patients with metastatic melanoma; and 2) Elucidate the mechanisms by which combined GR-MD-02/ipilimumab therapy boosts anti-tumor immunity.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2019 ( Subtotal = $0 )
2019	2016	PROVIDENCE HEALTH & SERVICES - OREGON	4805 NE GLISAN ST	PORTLAND	OR	97213	MULTNOMAH	USA	Cancer Treatment Research	000	2	12/17/2018	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2016 ( Subtotal = $185,992 )
2016	2016	PROVIDENCE PORTLAND MEDICAL CENTER	4805 NE GLISAN STREET	PORTLAND	OR	97213	MULTNOMAH	USA	Cancer Treatment Research	000	2	6/16/2016	NON-COMPETING CONTINUATION	$185,992
														Subtotal = $185,992

Issue Date FY: 2015 ( Subtotal = $153,038 )
2015	2015	PROVIDENCE PORTLAND MEDICAL CENTER	4805 NE GLISAN STREET	PORTLAND	OR	97213	MULTNOMAH	USA	Cancer Treatment Research	000	1	7/6/2015	NEW	$153,038
														Subtotal = $153,038

Grand Total All Awards = $339,030

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Ipilimumab plus a galectin-3 inhibitor for metastatic melanoma

Award Number: R21CA190790

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 07/06/2015

PERIOD OF PERFORMANCE END DATE: 06/30/2018

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