A Phase 2 interventional study of Cabozantinib 40 MG oral once a day and Pembrolizumab 200 mg IV every 3 weeks in Cervical Cancer, Recurrent Cervical Cancer and Metastatic Cervical Cancer, sponsored by University of South Alabama. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-07.
Sponsored by University of South Alabama · Phase 2, Interventional, and Treatment
Drug: Cabozantinib Drug: Pembrolizumab
This study is a multi-center, single arm, open label trial to evaluate the efficacy and safety of Cabozantinib (XL184) plus Pembrolizumab in recurrent, persistent and/or metastatic cervical cancer with PD-L1 tumor positivity.
1,927 studies on the registry are indexed under Uterine Cervical Neoplasms; 576 are open to participants now.
This study's enrollment of 5 is below the median of 100 across 1,411 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →University of South Alabama is the lead sponsor of 29 studies on the registry; 5 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
A Phase II Study of Cabozantinib (XL 184)Plus Pembrolizumab for Recurrent, Persistent and/or Metastatic Cervical Cancer
Drug: Cabozantinib 40 MG oral once a day · Drug: Pembrolizumab 200 mg IV every 3 weeks
Cabozantinib 40 mg oral once a day
Also known as: Cabometyx
Pembrolizumab 200 mg IV every 3 weeks
Also known as: Keytruda
Progression Free Survival
Six months progression free survival as defined by RECIST v1.1 measured from signed written consent to the date of first documented tumor progression using RECIST v1.1, or death due to any cause or 24 months after the end of study treatment.
Time frame: Up to 24 months
Overall Response Rate
Overall response defined by Response Evaluation Criteria in Solid Tumors (RECIST v.1.1 criteria).
Time frame: Up to 24 months
Overall Survival
Overall survival will be defined as the time from signed written consent to the date of death or 24 months after the end of study treatment. A patient who has not died will be censored at the last known date of contact
Time frame: Up to 24 months
Incidence of Emergent Adverse Events
Evaluate the safety and tolerability measured by incidence of adverse events and serious adverse events, deaths, and laboratory abnormalities as measured by Common Terminology Criteria for Adverse Events v.4.0
Time frame: Up to 6 Months
Cervical Cancer Quality of Life
Quality of life as assessed by FACT Cx quality of life questionnaire. This frequency questionnaire is scaled from 0-4 with 0 being not at all and 4 being very much.
Time frame: Up to 6 Months
Plan to share: No
This study is terminated, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Cabozantinib · Pembrolizumab
University of South Alabama