Research

Active Clinical Trials-Open to Enrollment

Psycho-Spiritual Support for Patients with Advanced Cancer and their Family Caregivers (Protocol 2023-0450)

The goal of this behavioral research study is to learn about the effects of two different supportive care programs on patients’ and their family caregivers’ psychological wellbeing and overall quality of life.

Participants will be asked to answer a set of questionnaires 4 times. Participants will be randomized to 1 of 3 following study groups. All sessions will be online by video conference using Zoom.

Group 1: participants will take part in the family-focused meditation program
Group 2: participants will take part in the family-focused cancer-related discussion program
Group 3: participants will not take part in the family-focused meditation or cancer-related discussion program but will complete the same questionnaires as Group 1 and 2

Eligibility Criteria: Patients must be diagnosed with metastatic (stage IV) breast, thoracic, gastrointestinal, gynecological, or genitourinary cancer; without disease progression for at least 3 months based on CT imaging surveillance; have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2; and have a family caregiver willing to consent to participate in this study. Patients and caregivers must be age 18 years and older; able to read and speak English or Spanish and provide consent; and have a NCCN Distress Thermometer score of ≥4.

Lead Physician: Julie Rowe, MD
Contact: Ayodeji (Ayo) Adeniji at 713-500-5570 or [email protected]

“A Phase 3 Randomized Double-blind Study of Adjuvant Pembrolizumab With or Without V940 in Participants With Resectable Stage II to IIIB (N2) NSCLC not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy (INTerpath-009)”

This trial will compare V940 (mRNa-4157) plus pembrolizumab to placebo plus pembrolizumab in participants after surgery to remove their non-small cell lung cancer (NSCLC). V940 is a type of mRNA (messenger ribonucleic acid) treatment. Each V940 treatment used in this trial will be custom made for the participant receiving it.

Eligibility Criteria:

Are at least 18 years old
Have NSCLC that is Stage 2, 3a, or 3b (N2)
Have NSCLC that can been removed surgically
Can provide a blood sample and tumor tissue sample from the surgery that removed your NSCLC. These samples will be tested to see if they meet trial requirements to create a V940 personalized treatment.
If you have already received pembrolizumab with chemo followed by surgery, you may still be able to join the trial.

A description of this clinical trial including eligibility criteria is available at http://www.ClinicalTrials.gov, as required by U.S. law. ClinicalTrials.gov identifier: NCT06623422

Lead Physician: Syed Jafri, MD
Contact: Kaukab Jafry at 832-325-6537 or [email protected]

A Phase 3 Study of Pembrolizumab in Combination With Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) followed by Pembrolizumab With or Without Maintenance MK‑2870 in the First-line Treatment of Metastatic Squamous Non small Cell Lung Cancer [MK-2870-023]

This is a phase 3 study of pembrolizumab in combination with carboplatin/taxane (paclitaxel or nab-paclitaxel) followed by pembrolizumab with or without maintenance study treatment sacituzumab tirumotecan (sac-TMT; MK-2870) in first-line treatment of metastatic squamous non-small cell lung cancer. It is hypothesized that pembrolizumab with maintenance sacituzumab tirumotecan is superior to pembrolizumab without sacituzumab tirumotecan maintenance with respect to overall survival (OS).

All participants undergo an initial induction phase of four cycles, each cycle consisting of pembrolizumab once every 3 weeks + carboplatin once every 3 weeks + paclitaxel once every 3 weeks or nabpaclitaxel weekly. Participants are then randomly assigned Group1 (participants will get study treatment MK-2870 once every 2 weeks and pembrolizumab once every 6 weeks) or Group 2 (participants will get pembrolizumab once every 6 weeks).

You can join this study if:

You are at least 18 years old;
You have newly diagnosed squamous NSCLC that has spread to other parts of your body (metastatic);
You have no prior treatment for your metastatic NSCLC. However, if you have already received chemotherapy (chemo) and/or radiation, you may still be able to join the trial. The trial doctor will discuss this with you.

A description of this clinical trial including eligibility criteria is available at http://www.ClinicalTrials.gov. ClinicalTrials.gov identifier: NCT06422143

Lead Physician: Syed Jafri, MD
Contact: Kaukab Jafry at 832-325-6537 or [email protected]

A Phase 1/1b, First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 in Participants with Advanced Solid Tumors (Protocol CP-MGC026-01)

The purpose of this study is to learn about the safety of the test drug MGC026, find the best dosage of the test drug, and to learn if, or how well, the test drug works in participants with locally advanced or metastatic solid tumors whose cancer has progressed during or after standard treatments. The study has a dose escalation and a cohort expansion portion. Participants will receive MGC026 by intravenous (IV) infusion. The dose of MGC026 will be assigned at the time of enrollment. Participants may receive up to 35 treatments if there are no severe side effects and as long as the cancer does not get worse.

Key Eligibility Criteria: You may be able to join this trial if you are 18 years of age or older, have adequate performance status, adequate organ function, and no underlying medical or psychiatric condition impairing your ability to receive, tolerate, or comply with planned study treatment dosing or study procedures.

A description of this clinical trial including eligibility criteria is available at http://www.ClinicalTrials.gov. ClinicalTrials.gov identifier: NCT06242470

Lead Physician: Julie Rowe, MD
Contact: Kaukab Jafry at 832-325-6537 or [email protected]

Endoscopic Ultrasound Radiofrequency Ablation and Immunotherapy Pembrolizumab for Metastatic Pancreatic Duct Adenocarcinoma; A Phase II Trial PANcreas CAncer RaDIofrequeNcy AbLation (PANCARDINAL-2)

The purpose of this study is to perform a pilot phase II trial to evaluate the safety and efficacy of combined EUS-RFA, chemotherapy, and systemic immunotherapy (pembrolizumab) for the treatment of locally advanced unresectable and metastatic pancreatic ductal adenocarcinoma (mPDAC).

Participants will undergo several sessions of EUS-RFA in combination with chemotherapy and immunotherapy, have regular testing for signs of disease progression using CT scan or MRI and safety lab tests. In addition, blood and tumor tissue will be collected during routine scheduled procedures for future research genetic testing. Participation will last for about 24 weeks.

A description of this clinical trial including eligibility criteria is available at http://www.ClinicalTrials.gov. ClinicalTrials.gov identifier: NCT06831136

Lead Physician: Putao Cen, MD
Contact: Kaukab Jafry at 832-325-6537 or [email protected]

Epigenetic Modulation of Inflammatory Pathways in Cancer-Related Depression (Short Title: Cancer-Mediated Depression)

The purpose of this study is to help researchers better understand the biological foundations of depression in patients with a new diagnosis of cancer. This may eventually lead to better management and treatment of depressive symptoms, which could ultimately improve patients’ prognosis.

Participants will be asked to answer questions during their routine clinic visit and provide some personal and basic health information. No additional study visits are required.

Key Eligibility Criteria includes patients with confirmed new diagnosis of gastrointestinal, lung, or breast cancer, cancer stage II-IV (locally advanced to metastatic), no prior psychiatric history, ages 18 and above, any sex and gender identification, and with capacity for voluntary participation, informed consent, and clinical psychiatric assessments.

Lead Researcher: Ning Olivia Zhao, MD
Contact: Betty Arceneaux at 713-704-3186 or [email protected]

Translational Trials-Open to Enrollment

Development of a Patient-Derived Xenograft Mouse Model of Solid Tumors

The purpose of this research study is to create patient-derived xenograft (PDX) mouse models and patient- derived organoids (PDO). PDX/PDO tumor models are created using a small portion of a patient’s left- over tumor tissue. In this study, researchers want to look at and compare the genetic changes of the tumor models with drug response and/or resistance.

Eligibility Criteria: Patients must be age 18 years and older, with solid tumors, undergoing cancer treatment at UTHealth/Memorial Hermann Hospital-Texas Medical Center, and able to provide a solid tumor sample (from a standard of care biopsy/surgery).

Lead Physician: Julie Rowe, MD
Contact: Betty Arceneaux at 713-704-3186 or [email protected]