This Clinical Trials Resource Guide lists actively recruiting clinical trials that focus on cervical cancer. They are examining the efficacy of adding nelfinavir to treatment regimens, using atezolizumab as an immunotherapy primer, combining metformin and doxycycline, adjuvant chemotherapy in addition to chemoradiation therapy, and adjuvant chemoradiation therapy compared with radiotherapy alone.
More information on these trials is available on the National Institutes of Health’s website at ClinicalTrials.gov.
PHASE I
Study Title: A Study of Nelfinavir Added to Cisplatin Chemotherapy Concurrent With Pelvic Radiation for Locally Advanced Cervical Cancer (II-IVA)
Study Type: Interventional/single-group assignment
Study Sponsor and Collaborators: Abramson Cancer Center of the University of Pennsylvania
Purpose: To deliver twice daily oral nelfinavir and weekly intravenous cisplatin in combination with daily whole pelvic external-beam and intracavity radiation brachytherapy to patients with clinical stages IIA, IIB, IIIA, IIIB, IVA cervical carcinoma limited to the pelvis
Primary Outcome Measures: Number of adverse events [time frame: 2 years]
Principal Investigators: Lilie Lin, MD, Abramson Cancer Center of the University of Pennsylvania, and Fiona Simpkins, MD, Abramson Cancer Center of the University of Pennsylvania; contact Dr. Simpkins, (855) 216-0098 or PennCancerTrials@emergingmed.com
ClinicalTrials.gov Identifier: NCT02363829
Study Title: Anti–PD-L1 (Atezolizumab) as an Immune Primer and Concurrently With Extended Field Chemoradiotherapy for Node-Positive Locally Advanced Cervical Cancer
Study Type: Interventional/parallel assignment
Study Sponsor and Collaborators: National Cancer Institute/NRG Oncology
Purpose: To determine whether differences in sequencing of atezolizumab and chemoradiation result in differential immune activation in patients with stage IB2, II, IIIB, or IVA cervical cancer that has spread to the lymph nodes
Primary Outcome Measures: T-cell receptor beta clonal expansion in peripheral blood [time frame: day 21]
Principal Investigator: Jyoti S. Mayadev, MD, NRG Oncology; contact Dr. Mayadev, (858) 822-5354 or cancercto@ucsd.edu. This clinical trial has locations in Alabama, California, Colorado, Georgia, Iowa, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Texas, and Wisconsin.
ClinicalTrials.gov Identifier: NCT03738228
PHASE II
Study Title: Metformin Hydrochloride and Doxycycline in Treating Patients With Localized Breast or Uterine Cancer
Study Type: Interventional/single-group assignment
Study Sponsor and Collaborators: Sidney Kimmel Cancer Center at Thomas Jefferson University
Purpose: To determine the efficacy of the combination treatment of metformin and doxycycline in treating patients with localized breast, uterine, or cervical cancers
Primary Outcome Measures: Within-patient change in the percent of stromal cells expressing caveolin-1 at an intensity of 1+ or greater, as assessed by immunohistochemistry [time frame: baseline to week 6]
Principal Investigator: Jennifer Johnson, MD, PhD, Thomas Jefferson University; contact Dr. Johnson, (215) 955-8874
ClinicalTrials.gov Identifier: NCT02874430
PHASE III
Study Title: Chemotherapy and Pelvic Radiation Therapy With or Without Adjuvant Chemotherapy in High-Risk Early-Stage Cervical Carcinoma After Radical Hysterectomy
Study Type: Interventional/parallel assignment
Study Sponsor and Collaborators: Radiation Therapy Oncology Group/National Cancer Institute/NRG Oncology
Purpose: To study how well chemotherapy and pelvic radiation therapy work when given with and without additional chemotherapy in treating patients with high-risk early-stage cervical carcinoma found to have positive nodes and/or positive parametria after radical hysterectomy
Primary Outcome Measures: Disease-free survival [time frame: from randomization to date of first failure (local, regional, or distant metastases or death due to any cause) or last follow-up]
Principal Investigator: Anuja Jhingran, MD, MD Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00980954
Study Title: Radiation Therapy With or Without Chemotherapy in Patients With Stage I-IIA Cervical Cancer Who Previously Underwent Surgery
Study Type: Interventional/parallel assignment
Study Sponsor and Collaborators: Gynecologic Oncology Group/National Cancer Institute
Purpose: To determine whether postoperative adjuvant chemoradiation therapy can significantly improve recurrence-free survival when compared with radiation therapy alone in patients with stage I-IIA cervical cancer with intermediate-risk factors after treatment with radical hysterectomy
Primary Outcome Measures: Recurrence-free survival [time frame: from protocol registration to date of first documented recurrence, death, or date of last contact, assessed up to 11 years]
Principal Investigator: Sang Y. Ryu, MD, NRG Oncology
ClinicalTrials.gov Identifier: NCT01101451
Editor’s Note: The clinical trials presented here do not represent all the trials listed on ClinicalTrials.gov. For the complete list, go to ClinicalTrials.gov.
