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 Phase lb Study of ASPl948, Targeting an Immune Modulatory Receptor, as a Single Agent and in Combination with a PD-I inhibitor (Nivolumab or Pembrolizumab) in Subjects with Advanced Solid Tumors

Date Added
July 23rd, 2019
PRO Number
Pro00087949
Researcher
John Wrangle

List of Studies


Keywords
Cancer, Cancer/Breast, Cancer/Genitourinary, Cancer/Gynecological, Cancer/Head & Neck, Cancer/Lung
Summary

This is a research study to find out if the study drug (ASP1948 or ASP1948 plus nivolumab or pembrolizumab) is safe and to determine the safest, most effective dose of the drug. When the safe dose is identified, it will be used to evaluate if the study treatment causes tumors to shrink in patients. During this study, the study drug will be continuously assessed to determine if it is safe and tolerated by patients taking it. The following adverse events have been reported in more than 10% of patients: fatigue, abdominal pain, decreased appetite, back pain, dyspnea (difficulty breathing), hyponatraemia (low sodium levels), anemia (low red cell count), and constipation. Since these events may occur in patients not taking ASP1948 and since there have been no clinical trials comparing patients taking ASP1948 with those not taking ASP1948, it is difficult to know at this time whether they were caused by ASP1948.

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

A PHASE III TRIAL OF ADJUVANT CHEMOTHERAPY AS PRIMARY TREATMENT FOR LOCALLY ADVANCED CERVICAL CANCER COMPARED TO CHEMORADIATION ALONE: THE OUTBACK TRIAL (ANZGOG 0902/GOG-0274/RTOG 1174)

Date Added
March 12th, 2012
PRO Number
Pro00016094
Researcher
Samuel Cooper

List of Studies


Keywords
Cancer, Cancer/Gynecological
Summary

The objectives of this trial are to find out whether adjuvant chemotherapy (using two other drugs) after chemo-radiation will increase the chances of survival and reduce the risk of tumor recurrence in the pelvis and other places. The risk and severity of side effects and quality of life during and after treatment will also be evaluated and compared. This trial will help the researchers understand the safety and effectiveness of this new treatment regimen for cervical cancer.

Institution
MUSC
Recruitment Contact
Shanta Salzer
843-792-1463
salzers@musc.edu



-- OR --