NCT06788990 - FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC | Biotech Hunter

Enrollment

650

Participants

Timeline

Start Date

January 28, 2025

Primary Completion Date

April 30, 2028

Study Completion Date

July 31, 2029

Conditions

Metastatic Head and Neck Squamous Cell CarcinomaRecurrent Head and Neck Squamous Cell Carcinoma

Interventions

DRUG

Ficerafusp alfa

Investigational

DRUG

Pembrolizumab (KEYTRUDA®)

Immunotherapy agent used in combination with investigational agent

DRUG

Placebo

Placebo Control

Trial Locations (52)

2050

RECRUITING

Site#0302, Camperdown

2298

RECRUITING

Site#0304, Waratah

2747

RECRUITING

Site #0306, Kingswood

3010

RECRUITING

Site#0402, Rotorua

3051

RECRUITING

Site#0301, North Melbourne

3084

RECRUITING

Site #0303, Heidelberg

4215

RECRUITING

Site #0305, Southport

4224

RECRUITING

Site#0307, Tugun

6150

RECRUITING

Site#0308, Murdoch

8011

RECRUITING

Site #0401, Christchurch

10021

RECRUITING

Site#0142, New York

15206

RECRUITING

Site #0103, Pittsburgh

15240

RECRUITING

Site #0123, Pittsburgh

19713

RECRUITING

Site#0127, Newark

21201

RECRUITING

Site #0112, Baltimore

22904

RECRUITING

Site#0134, Charlottesville

23219

RECRUITING

Site #0129, Richmond

27703

RECRUITING

Site#0118, Durham

29425

RECRUITING

Site#0104, Charleston

32901

RECRUITING

Site #0136, Palm Bay

33612

RECRUITING

Site #0105, Tampa

35233

RECRUITING

Site # 0137, Birmingham

37203

RECRUITING

Site#0126, Nashville

40202

RECRUITING

Site#0111, Louisville

RECRUITING

Site#0115, Louisville

40536

RECRUITING

Site#0109, Lexington

44106

RECRUITING

Site #0151, Cleveland

44195

RECRUITING

Site #0108, Cleveland

44708

RECRUITING

Site#0154, Canton

45221

RECRUITING

Site#0117, Cincinnati

52242

RECRUITING

Site#0140, Iowa City

60064

RECRUITING

Site #0133, Chicago

66205

RECRUITING

Site #0149, Westwood

77005

RECRUITING

Site#0102, Houston

80012

RECRUITING

Site #0122, Aurora

80045

RECRUITING

Site #0124, Aurora

RECRUITING

Site#0121, Aurora

90095

RECRUITING

Site #0106, Los Angeles

92093

RECRUITING

Site #0107, La Jolla

94305

RECRUITING

Site #0150, Stanford

95817

RECRUITING

Site#0144, Sacramento

97213

RECRUITING

Site #0113, Portland

98109

RECRUITING

Site #0125, Seattle

98684

RECRUITING

Site#0120, Vancouver

02114

RECRUITING

Site #0131, Boston

02136

RECRUITING

Site#0101, Boston

07601

RECRUITING

Site #0119, Hackensack

02903

RECRUITING

Site #0132, Providence

V5Z 4E6

RECRUITING

Site #0202, Vancouver

H2X 0C1

RECRUITING

Site #0203, Montreal

SW3 6JJ

RECRUITING

Site #0505, London

SM2 5PT

RECRUITING

Site # 0501, Sutton