Spots Global Cancer Trial Database for Combination Therapy With NC-6004 and Pembrolizumab in Head and Neck Cancer Subjects Who Have Failed Platinum Regimen
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Trial Identification
Brief Title: Combination Therapy With NC-6004 and Pembrolizumab in Head and Neck Cancer Subjects Who Have Failed Platinum Regimen
Official Title: Phase IIa/IIb Clinical Trial of NC-6004 in Combination With Pembrolizumab in Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Who Have Failed Platinum or a Platinum-containing Regimen
Study ID: NCT03771820
Conditions
Study Description
Brief Summary: In Phase IIa, dose-escalation study to determine the optimum tolerated dose and a recommended Phase IIb (RPIIb) dose in combination with pembrolizumab in subjects with recurrent or metastatic squamous cell carcinoma of the head and neck who have failed platinum or a platinum containing regimen. In Phase IIb, randomized control study between NC-6004 in combination with pembrolizumab versus pembrolizumab alone in the same subject population as Part 1 at the RPIIb dose identified in PIIa.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
0603, Osijek, , Croatia
0601, Zagreb, , Croatia
0602, Zagreb, , Croatia
0701, Brno, , Czechia
0702, Hradec Králové, , Czechia
0703, Olomouc, , Czechia
0104, Budapest, , Hungary
0105, Debrecen, , Hungary
0103, Kecskemét, , Hungary
0101, Pécs, , Hungary
0202, Bydgoszcz, , Poland
0201, Łódź, , Poland
0801, Ekaterinburg, , Russian Federation
0802, Omsk, , Russian Federation
0301, Belgrade, , Serbia
0303, Niš, , Serbia
0301, Sremska Kamenica, , Serbia
0404, Taichung City, , Taiwan
0402, Taipei city, , Taiwan
0403, Taipei city, , Taiwan
0401, Taoyuan City, , Taiwan
0902, Cherkasy, , Ukraine
0903, Ivano-Frankivs'k, , Ukraine
0904, Kharkiv, , Ukraine
Contact Details
Name: Atsushi Osada
Affiliation: NanoCarrier US LLC
Role: STUDY_DIRECTOR
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