Nanatinostat Plus Valganciclovir in Advanced EBV+ Solid Tumors and in Combination With Pembrolizumab in EBV+ RM-NPC
- Trial number:
- NCT05166577
- Trial phase:
- 1
- Study type:
- Immunotherapy, Biomarker
- Overall status:
- Terminated
Study start date
October, 2021
Scientific title
Open-Label Multicenter Phase 1b/2 Study of Nanatinostat + Valganciclovir in Patients With Advanced Epstein-Barr Virus-Positive Solid Tumors and in Combination With Pembrolizumab in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma
Summary
This study will evaluate the safety and efficacy of nanatinostat in combination with valganciclovir in patients with relapsed/refractory EBV-positive solid tumors and in combination with pembrolizumab in patients with recurrent/metastatic nasopharyngeal carcinoma
Key
* Recurrent or metastatic EBV+ nasopharyngeal carcinoma (RM-NPC) for whom no potentially curative options are available, who have received at least 1 prior line of platinum-based chemotherapy and no more than 3 prior lines of therapy for RM-NPC.* Phase 1b exploratory proof-of-concept cohort only: Advanced/metastatic EBV+ non-NPC solid tumors with no available curative therapies. * Measurable disease per RECIST v1.1 * ECOG performance status 0 or 1 * Adequate bone marrow and liver function
Key
Study design
Primary purpose:
TREATMENT, Allocation:
RANDOMIZED, Intervention model:
PARALLEL, Intervention model description:
A traditional 3+3 dose escalation design followed first by a dose optimization cohort and then by dose expansion with 1:1 randomization to receive nanatinostat and valganciclovir with or without pembrolizumab in Phase 2., , The study was prematurely terminated after the end of Phase 1b and did not proceed to Phase 2.
, Masking:
NONE,
Conditions
Nasopharyngeal Carcinoma, EBV-Related Gastric Carcinoma, EBV-Related Leiomyosarcoma, EBV Related Carcinoma, EBV-Related Sarcoma
Other study ID numbers
VT3996-301
Choose trial site (30)
Stanford Cancer Center
875 Blake Wilbur Dr, Stanford, CA 94305, USA
The Oncology Institute of Hope and Innovation
21605 Hawthorne Blvd Suite 200, Torrance, CA 90503, USA
Blacktown Hospital
18 Blacktown Rd, Blacktown NSW 2148, Australia
Princess Margaret Cancer Centre
610 University Ave, Toronto, ON M5G 2C1, Canada
Queen Mary Hospital
Queen Mary Hospital Main Block, Pok Fu Lam Rd, Pok Fu Lam, Hong Kong
Hong Kong United Oncology Centre
Hong Kong, Kwun Tong, Cha Kwo Ling Rd, 88號, Laguna Plaza, Shop 59A, 1/F
Prince Of Wales Hospital, The Chinese University Of Hong Kong
Li Ka Shing Medical Sciences Building, Ngan Shing St, Sha Tin, Hong Kong
Sarawak General Hospital
Jalan Hospital, 93586 Kuching, Sarawak, Malaysia
University of Malaya Medical Centre
Jln Profesor Diraja Ungku Aziz, 59100 Kuala Lumpur, Selangor, Malaysia
National Cancer Institute (Institut Kanser Negara)
4, Jalan P7, Presint 7, 62250 Putrajaya, Wilayah Persekutuan Putrajaya, Malaysia
National Cancer Centre Singapore
11 Hospital Cres, Singapore 169610
Tan Tock Seng Hospital
11 Jln Tan Tock Seng, Singapore 308433
National Taiwan University Hospital
No. 7號, Zhongshan S Rd, Zhongzheng District, Taipei City, Taiwan 100
Taipei Veterans General Hospital
No. 201, Section 2, Shipai Rd, Beitou District, Taipei City, Taiwan 112
Mackay Memorial Hospital
No. 92號, Section 2, Zhongshan N Rd, Zhongshan District, Taipei City, Taiwan 104
Linkou Chang Gung Memorial Hospital
No. 5, Fuxing St, Guishan District, Taoyuan City, Taiwan 333
The Oncology Institute of Hope and Innovation
3628 E Imperial Hwy #401, Lynwood, CA 90262, USA
University of Colorado Hospital
Aurora, CO 80045, USA
University of Texas MD Anderson Cancer Center
1515 Holcombe Blvd, Houston, TX 77030, USA
Blacktown Hospital
18 Blacktown Rd, Blacktown NSW 2148, Australia
Macquarie University
Sydney NSW, Australia
Princess Margaret Cancer Centre
610 University Ave, Toronto, ON M5G 2C1, Canada
Samsung Medical Center
81 Irwon-ro, Gangnam-gu, Seoul, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
222 Banpo-daero, Seocho-gu, Seoul, South Korea