Not provided
Not provided
Not provided
Not provided
Not provided
PI left institution
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Exelixis | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cabozantinib (XL 184) Plus Pembrolizumab | Experimental | A Phase II Study of Cabozantinib (XL 184)Plus Pembrolizumab for Recurrent, Persistent and/or Metastatic Cervical Cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cabozantinib 40 MG oral once a day | Drug | Cabozantinib 40 mg oral once a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | Overall response defined by Response Evaluation Criteria in Solid Tumors (RECIST v.1.1 criteria). | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stefanie White | University of South Alabama | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Alabama Mitchell Cancer Institute | Mobile | Alabama | 36604 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19825956 | Background | Karim R, Jordanova ES, Piersma SJ, Kenter GG, Chen L, Boer JM, Melief CJ, van der Burg SH. Tumor-expressed B7-H1 and B7-DC in relation to PD-1+ T-cell infiltration and survival of patients with cervical carcinoma. Clin Cancer Res. 2009 Oct 15;15(20):6341-7. doi: 10.1158/1078-0432.CCR-09-1652. Epub 2009 Oct 13. | |
| 23521696 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Pembrolizumab 200 mg IV every 3 weeks | Drug | Pembrolizumab 200 mg IV every 3 weeks |
|
|
| 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 | 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. | Up to 6 Months |
| Yang W, Song Y, Lu YL, Sun JZ, Wang HW. Increased expression of programmed death (PD)-1 and its ligand PD-L1 correlates with impaired cell-mediated immunity in high-risk human papillomavirus-related cervical intraepithelial neoplasia. Immunology. 2013 Aug;139(4):513-22. doi: 10.1111/imm.12101. |
| 21926191 | Background | Yakes FM, Chen J, Tan J, Yamaguchi K, Shi Y, Yu P, Qian F, Chu F, Bentzien F, Cancilla B, Orf J, You A, Laird AD, Engst S, Lee L, Lesch J, Chou YC, Joly AH. Cabozantinib (XL184), a novel MET and VEGFR2 inhibitor, simultaneously suppresses metastasis, angiogenesis, and tumor growth. Mol Cancer Ther. 2011 Dec;10(12):2298-308. doi: 10.1158/1535-7163.MCT-11-0264. Epub 2011 Sep 16. |
| 30943124 | Background | Chung HC, Ros W, Delord JP, Perets R, Italiano A, Shapira-Frommer R, Manzuk L, Piha-Paul SA, Xu L, Zeigenfuss S, Pruitt SK, Leary A. Efficacy and Safety of Pembrolizumab in Previously Treated Advanced Cervical Cancer: Results From the Phase II KEYNOTE-158 Study. J Clin Oncol. 2019 Jun 10;37(17):1470-1478. doi: 10.1200/JCO.18.01265. Epub 2019 Apr 3. |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 22, 2022 | Aug 16, 2022 | 9 | ||
| Aug 26, 2022 | Sep 21, 2022 | 10 |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| D000230 | Adenocarcinoma |
| D018196 | Carcinoma, Adenosquamous |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
| D018193 | Neoplasms, Complex and Mixed |
Not provided
Not provided
| ID | Term |
|---|---|
| C558660 | cabozantinib |
| C582435 | pembrolizumab |
Not provided
Not provided
Not provided