A RANDOMIZED PHASE II TRIAL OF TRIPLET THERAPY (A PD-L1 INHIBITOR DURVALUMAB (MEDI4736) IN COMBINATION WITH OLAPARIB AND CEDIRANIB) COMPARED TO OLAPARIB AND CEDIRANIB OR DURVALUMAB (MEDI4736) AND CEDIRANIB OR STANDARD OF CARE CHEMOTHERAPY IN WOMEN WITH PLATINUM-RESISTANT RECURRENT EPITHELIAL OVARIAN CANCER, PRIMARY PERITONEAL OR FALLOPIAN CANCER WHO HAVE RECEIVED PRIOR BEVACIZUMAB

Date Added
May 5th, 2022
PRO Number
Pro00120435
Researcher
Whitney Graybill

List of Studies


Keywords
Cancer/Gynecological
Summary

This study is for women with recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer that is resistant to platinum-based chemotherapy and have had prior therapy with bevacizumab.The purpose of the study is to see if the combinations of durvalumab (MEDI4736) plus olaparib and cediranib, durvalumab (MEDI4736) and cediranib, or olaparib and cediranib keep patients disease free longer than the usual approach.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
(843) 792-9321
hcc-clinical-trials@musc.edu

A Phase 3, Randomized, Double-Blind, Adaptive, Placebo/Paclitaxel-Controlled Study of AVB-S6-500 in Combination With Paclitaxel in Patients With Platinum-Resistant Recurrent Ovarian Cancer

Date Added
November 23rd, 2021
PRO Number
Pro00113024
Researcher
Whitney Graybill

List of Studies


Keywords
Cancer, Cancer/Gynecological, Drug Studies, Women's Health
Summary

This study is for subjects that have platinum-resistant recurrent ovarian cancer. The study is testing an "investigational" study drug called AVB-S6-500. The primary purpose of this study is to evaluate the safety and efficacy of AVB-S6-500 combined with PAC in subjects with platinum-resistant, recurrent ovarian cancer. The subjects may remain in the study for up to 24-months. The subjects will be seen at MUSC every 1 to 2 weeks while receiving study treatment and given the study drug by infusion (IV).

Institution
MUSC
Recruitment Contact
HCC Clinical Trails Office
843-792-9321
hcc-clinical-trials@musc.edu

A Phase 1b/2, First-in-Human, Dose Escalation and Expansion Study of XMT-1536 In Patients with Solid Tumors Likely to Express NaPi2b

Date Added
August 10th, 2021
PRO Number
Pro00112310
Researcher
Brian Orr

List of Studies

Keywords
Cancer, Cancer/Gynecological, Drug Studies
Summary

This study is for subjects with ovarian and non-small cell lung cancer. The investigational drug used is XMT-1536 (upifitamab rilsodotin). The drug will be given intravenously "IV" during infusion.
This study will focus on two parts: dose expansion (increasing the dose used) and the pivotal cohort (safety and usefulness of UPLIFT). The purpose of the second part of the study (dose expansion) is to study further the expansion dose (increasing of the dose) of XMT-1536. The research is done based on the data from the first part of the study to ensure that it can be tolerated and is safe. The third part of this study (UPLIFT) will further study the dose recommended in the first part of the study in subjects with ovarian cancer. UPLIFT is used to determine the subjects' response rate to the study drug and the length of time the drug stays in the blood. The subjects will be in the study for 18 months.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Phase 1b Study of ASP1951, a GITR Agonistic Antibody, as a Single Agent and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors

Date Added
February 23rd, 2021
PRO Number
Pro00106203
Researcher
John Kaczmar

List of Studies


Keywords
Cancer, Cancer/Gastrointestinal, Cancer/Genitourinary, Cancer/Gynecological, Cancer/Head & Neck, Cancer/Lung, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have a tumor that cannot be removed through surgery (unresectable) or may have spread (metastasized) to other parts of their body. In this study, ASP1951 will be given alone (monotherapy) or combined with pembrolizumab (combination therapy). Both ASP1951 and pembrolizumab will be considered study drug. Pembrolizumab has been approved by FDA for use in patients with skin, lung, cervical cancer, certain cancers of head and neck and other cancers but may not be approved to treat all types of cancer. However, the use of ASP1951 plus pembrolizumab has not been approved by regulatory authorities and is therefore investigational. The study consists of 3 periods: screening (up to 28 days), treatment (up to 48 weeks [16 cycles]) and follow up (up to 45 weeks), followed by an optional re-treatment period for participants that qualify. The re-treatment period will allow participants to receive study drug treatment again for up to 16 additional cycles (approximately 48 weeks), for a maximum total treatment and re-treatment period of 32 cycles (approximately 96 weeks). Both study drugs are administered intravenously (into the vein).This is the first time the investigational study drug ASP1951 is being tested in humans; however, studies in animals showed that the study drug is safe to be tested in humans.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Randomized, Phase 3, Double-Blind Study of Chemoradiotherapy With or Without Pembrolizumab for the Treatment of High-risk, Locally Advanced Cervical Cancer (KEYNOTE-A18 / ENGOT-cx11)

Date Added
February 7th, 2020
PRO Number
Pro00103304
Researcher
Samuel Cooper

List of Studies


Keywords
Cancer, Cancer/Gynecological, Drug Studies, Women's Health
Summary

This study is for patient that have been diagnosed with high-risk locally advanced cervical cancer. High-risk locally advanced cervical cancer includes participants who have Stage IB2-IIB disease with pelvic or para-aortic lymph node involvement or more advanced stages of locally advanced cervical cancer. The purpose of this study is to test the safety of the study drug, pembrolizumab, when given with chemoradiotherapy and to see how it works when given with chemotherapy and compares to treatment with chemotherapy alone. Participants can expect to be treated with study drugs for about 2 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Phase III Randomized, Placebo-Controlled Study of Pembrolizumab (MK-3475, NSC #776864) in Addition to Paclitaxel and Carboplatin for Measurable Stage III or IVA, Stage IVB or Recurrent Endometrial Cancer

Date Added
October 23rd, 2019
PRO Number
Pro00093541
Researcher
Whitney Graybill

List of Studies


Keywords
Cancer/Gynecological
Summary

This study is for women with endometrial cancer. The purpose is to find out if adding a new immunotherapy drug to the usual combination of chemotherapy drugs can lower the chance of your endometrial cancer growing or spreading.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Randomized Phase II/III Study of Paclitaxel/Carboplatin/Metformin (NSC#91485) Versus Paclitaxel/Carboplatin/Placebo as Initial Therapy for Measurable Stage III or IVA, Stage IVB, or Recurrent Endometrial Cancer

Date Added
April 30th, 2014
PRO Number
Pro00034096
Researcher
Whitney Graybill

List of Studies


Keywords
Cancer/Gynecological, Women's Health
Summary

This study is for adult women who have advanced or recurrent endometrial (uterine) cancer. The purpose is to find out if the drug combination of paclitaxel, carboplatin and metformin works better than paclitaxel and carboplatin alone in treating uterine cancer.

Institution
MUSC
Recruitment Contact
Sarah Booker
843-792-9190
bookers@musc.edu



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