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SRK-181 Alone or in Combination With Anti-PD-(L)1 Antibody Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (DRAGON)

This is a multi-center, open-label, Phase 1, first-in-human (FIH), dose-escalation, and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of SRK-181 administered alone and in combination with anti-PD-(L)1 therapy in adult patients with locally advanced or metastatic solid tumors. The study is divided into 3 treatment parts (Part A1, Part A2, and Part B) and a Long-Term Extension Phase (LTEP).

Phase: Phase 1
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Kimberly Kelly

A Study of Treatment for Medulloblastoma Using Sodium Thiosulfate to Reduce Hearing Loss

This phase III trial tests two hypotheses in patients with low-risk and average-risk medulloblastoma. Medulloblastoma is a type of cancer that occurs in the back of the brain. The term, risk, refers to the chance of the cancer coming back after treatment. Subjects with low-risk medulloblastoma typically have a lower chance of the cancer coming back than subjects with average-risk medulloblastoma. Although treatment for newly diagnosed average-risk and low-risk medulloblastoma is generally effective at treating the cancer, there are still concerns about the side effects of such treatment. Side effects or unintended health conditions that arise due to treatment include learning difficulties, hearing loss or other issues in performing daily activities. Standard therapy for newly diagnosed average-risk or low-risk medulloblastoma includes surgery, radiation therapy, and chemotherapy (including cisplatin). Cisplatin may cause hearing loss as a side effect. In the average-risk medulloblastoma patients, this trial tests whether the addition of sodium thiosulfate (STS) to standard of care chemotherapy and radiation therapy reduces hearing loss. Previous studies with STS have shown that it may help reduce or prevent hearing loss caused by cisplatin. In the low-risk medulloblastoma patients, the study tests whether a less intense therapy (reduced radiation) can provide the same benefits as the more intense therapy. The less intense therapy may cause fewer side effects. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. The overall goals of this study are to see if giving STS along with standard treatment (radiation therapy and chemotherapy) will reduce hearing loss in medulloblastoma patients and to compare the overall outcome of patients with medulloblastoma treated with STS to patients treated without STS on a previous study in order to make sure that survival and recurrence of tumor is not worsened.

Phase: Phase 3
Primary Purpose: Treatment
Gender: All
Age Group: Adults, Children
Contact: MIKAYLA HENDERSON

A Phase 2, Randomized, Open-label Study of Onvansertib in Combination with FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab Versus FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab for First-line Treatment of Metastatic Colorectal Cancer in Patients with a KRAS or NRAS Mutation

This study has not yet been registered on ClinicalTrials.gov, which is currently a pre-requisite for display of detailed eligibility criteria.

Phase: Phase 2
Age Group: Adults
Contact: Ruth Gonzalez
Open Actively Recruiting

A Study of NT-112 in HLA-C*08:02-Positive Adult Subjects With Unresectable, Advanced, and/ or Metastatic Solid Tumors Positive for the KRAS G12D Mutation

Phase I Study of NT-112, an autologous T-cell therapy product genetically engineered to express an HLA-C*08:02-restricted T cell receptor (TCR), targeting KRAS G12D mutant solid tumors.

Phase: Phase 1
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Chris Hannigan
Open Actively Recruiting

Study to Evaluate Adverse Events, and Change in Disease Activity, When Intravenously (IV) Infused With Livmoniplimab in Combination With IV Infused Budigalimab in Adult Participants With Hepatocellular Carcinoma (HCC)

Hepatocellular carcinoma (HCC) is a common cancer worldwide and a leading cause of cancer-related death. The majority of participants first presenting with HCC have advanced unresectable or metastatic disease. The purpose of this study is to evaluate the optimized dose, adverse events, and efficacy of livmoniplimab in combination with budigalimab.

Livmoniplimab is an investigational drug being developed for the treatment of HCC. There are 3 treatment arms in this study and participants will be randomized in a 1:1:1 ratio. Participants will either receive livmoniplimab (at different doses) in combination with budigalimab (another investigational drug), lenvatinib, or sorafenib. Approximately 120 adult participants will be enrolled in the study across 60 sites worldwide.

In arm 1 (control), participants will receive the investigator's choice: lenvatinib as an oral capsule or sorafenib as an oral tablet, once daily. In arm 2, participants will receive intravenously (IV) infused livmoniplimab (dose A) in combination with IV infused budigalimab, every 3 weeks. In arm 3, participants will receive intravenously (IV) infused livmoniplimab (dose B) in combination with IV infused budigalimab, every 3 weeks. The estimated duration of the study is up to 2 years

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.

Phase: Phase 2
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Brian Donnellan
Open Actively Recruiting

Study of [18F]FAPI-74 PET in Patients With Gastrointestinal Cancers

Prospective, multi-center, open label, non-randomized clinical trial to assess efficacy of [18F]FAPI-74 to detect FAP expressing cells in patients diagnosed with gastrointestinal cancers, including hepatocellular carcinoma, cholangiocarcinoma, gastric, pancreatic and colorectal cancer. The [18F]FAPI-74 PET scan will be acquired in patients with proven GI cancers after initial staging using institutional standard methods. The PET scan results will be compared to FAP immunohistochemistry (as the primary objective) and histopathology (as the secondary objective) of the biopsied or resected tissues.

Phase: Phase 2
Primary Purpose: Diagnostic
Gender: All
Age Group: Adults
Contact: Aletta Deranteriassian
Open Actively Recruiting

IO-202 as Monotherapy and IO-202 Plus Azacitidine ± Venetoclax in Patients in AML and CMML

To assess safety and tolerability at increasing dose levels of IO-202 in successive cohorts of participants with AML with monocytic differentiation and CMML in order to estimate the maximum tolerated dose (MTD) or maximum administered dose (MAD) and select the recommended Phase 2 dose (RP2D)

Phase: Phase 1
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Bruck Habtemariam
Open Actively Recruiting

Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer

The study is intended to assess the safety and efficacy of perioperative treatment with Durvalumab in combination with Oleclumab, Monalizumab or AZD0171 and platinum doublet chemotherapy (CTX); or Volrustomig in combination with platinum doublet chemotherapy or datopotamab deruxtecan (Dato-DXd) in combination with durvalumab and single agent platinum chemotherapy in participants with resectable, early-stage non-small cell lung cancer.

Phase: Phase 2
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Dawit Hailu
Investigator: Jay M. Lee, MD
Open Actively Recruiting

Study of Biomarker-Based Treatment of Acute Myeloid Leukemia

This screening and multi-sub-study Phase 1b/2 trial will establish a method for genomic screening followed by assigning and accruing simultaneously to a multi-study "Master Protocol (BAML-16-001-M1)." The specific subtype of acute myeloid leukemia will determine which sub-study, within this protocol, a participant will be assigned to evaluate investigational therapies or combinations with the ultimate goal of advancing new targeted therapies for approval. The study also includes a marker negative sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies.

Phase: Phase 1/Phase 2
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Vladimir Kustanovich

A Study to Test the Addition of the Drug Cabozantinib to Chemotherapy in Patients With Newly Diagnosed Osteosarcoma

This phase II/III trial tests the safety, side effects, and best dose of the drug cabozantinib in combination with standard chemotherapy, and to compare the effect of adding cabozantinib to standard chemotherapy alone in treating patients with newly diagnosed osteosarcoma. Cabozantinib is in a class of medications called kinase inhibitors which block protein signals affecting new blood vessel formation and the ability to activate growth signaling pathways. This may help slow the growth of tumor cells. The drugs used in standard chemotherapy for this trial are methotrexate, doxorubicin, and cisplatin (MAP). Methotrexate stops cells from making DNA and may kill tumor cells. It is a type of antimetabolite. Doxorubicin is in a class of medications called anthracyclines. It works by slowing or stopping the growth of tumor cells in the body. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Adding cabozantinib to standard chemotherapy may work better in treating newly diagnosed osteosarcoma.

Phase: Phase 2/Phase 3
Primary Purpose: Treatment
Gender: All
Age Group: Adults, Children
Contact: MIKAYLA HENDERSON
Open Actively Recruiting

Investigating Safety, Tolerability, Efficacy and PK of Olaparib in Paediatric Patients With Solid Tumours

A study to find out whether olaparib is safe and well tolerated when administered to children and adolescents with solid tumours.

Phase: Phase 1
Primary Purpose: Treatment
Gender: All
Age Group: Adults, Children
Contact: Stacy Zamora
Open Actively Recruiting

A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Physician's Choice Chemotherapy in PD-(L)1-refractory, Relapsed or Refractory Classical Hodgkin Lymphoma (MK-4280A-008)

The purpose of this study is to compare efficacy of coformulated favezelimab/pembrolizumab (MK-4280A) with physician's choice chemotherapy of bendamustine or gemcitabine in participants with PD-(L)1-refractory, relapsed or refractory classical Hodgkin Lymphoma. The study will also assess the safety and tolerability of coformulated favezelimab/pembrolizumab. The primary study hypotheses are that coformulated favezelimab/pembrolizumab is superior to physician's choice chemotherapy with respect to progression-free survival (PFS) and overall survival (OS).

Phase: Phase 3
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Marvin Valencia
Open Actively Recruiting

Selinexor in Maintenance Therapy After Systemic Therapy for Participants With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma

The purpose of this study is to evaluate the efficacy and safety of selinexor as a maintenance treatment in patients with p53 wt endometrial carcinoma (EC), who have achieved a partial response (PR) or complete response (CR) (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v 1.1]) after completing at least 12 weeks of platinum-based therapy. A total of 220 participants will be enrolled in the study and randomized in a 1:1 ratio to maintenance therapy with either selinexor or placebo.

Phase: Phase 3
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Surya Nagesh
Open Actively Recruiting

Pancreatic Cancer Early Detection Consortium

The purpose of the Pancreatic Cancer Early Detection (PRECEDE) Consortium is to conduct research on multiple aspects of early detection and prevention of pancreatic ductal adenocarcinoma (PDAC) by establishing a multisite cohort of individuals with family history of PDAC and/or individuals carrying pathogenic/likely pathogenic germline variants (PGVs) in genes linked to PDAC risk for longitudinal follow up.

Phase: N/A (Cancer Prevention)
Gender: All
Age Group: Adults
Contact: Aletta Deranteriassian
Open Actively Recruiting

EFIRM Liquid Biopsy Research Laboratory: Early Lung Cancer Assessment

This study has not yet been registered on ClinicalTrials.gov, which is currently a pre-requisite for display of detailed eligibility criteria.

Phase: N/A
Age Group: Adults
Contact: MEGUMI YOKOMIZO
Open Actively Recruiting

An Expanded Access Program for the non-invasive detection of clear cell renal cell carcinoma in patients with renal masses utilizing 89Zirconium-labelled girentuximab (89Zr-DFO-girentuximab)

This study has not yet been registered on ClinicalTrials.gov, which is currently a pre-requisite for display of detailed eligibility criteria.

Phase: N/A
Age Group: Adults
Contact: Ankush Sachdeva
Open Actively Recruiting

Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer

The main objective is to compare the efficacy of tarlatamab with standard of care (SOC) on prolonging overall survival (OS).

Phase: Phase 3
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Joanna Gutierrez
Open Actively Recruiting

Study of BMS-986393 a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma

The purpose of this study is to evaluate the effectiveness and safety of BMS-986393 in participants with relapsed or refractory multiple myeloma.

Phase: Phase 2
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Chris Hannigan
Open Actively Recruiting

A Clinical Study of V940 Plus Pembrolizumab in People With High-Risk Melanoma (V940-001)

The purpose of this study is to learn if V940 which is an individualized neoantigen therapy (INT; formerly, called messenger ribonucleic acid [mRNA]-4157) with pembrolizumab (MK-3475) is safe and prevents cancer from returning in people with high-risk melanoma. Researchers want to know if V940 with pembrolizumab is better than receiving pembrolizumab alone at preventing the cancer from returning.

Phase: Phase 3
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: MARIA ZAMUDIO
Investigator: Antoni Ribas, MD
Open Actively Recruiting

A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)

The purpose of this study is to assess the efficacy and safety of opevesostat plus hormone replacement therapy (HRT) compared to alternative abiraterone acetate or enzalutamide in participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) previously treated with one next-generation hormonal agent (NHA). The primary study hypotheses are that opevesostat is superior to alternative abiraterone acetate or enzalutamide with respect to radiographic progression free survival (rPFS) per Prostate Cancer Working Group (PCWG) Modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and overall survival (OS), in androgen receptor ligand binding domain (AR LBD) mutation positive and negative participants.

Phase: Phase 3
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Sandy Hernandez