NEO-SPACE Trial: Pembrolizumab and Chemoradiation in Nasopharyngeal Cancer

NCT03734809 | Active Not Recruiting Phase 2 Results

• 1 other identifier: NPC032
• Study Type: interventional
• Target: 43
• Locations: 2 countries
• Sites: 2

Brief Summary

This is an open label, single arm, non-randomized, multi-site, phase 2 clinical trial of neoadjuvant pembrolizumab in combination with gemcitabine-cisplatin for 2 cycles,followed by concurrent pembrolizumab-cisplain-radiation, and then maintainence pembrolizumab monotherpy given every 3 weeks for a total treatment duration of 12 months, in previously untreated stage IVA ( UICC 8 th Edition ) nasopharyngeal cancer(NPC).

Conditions

NPC

Outcome Measures

Primary Outcomes (1)

• Two-year Progression Free Survival

  Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1), including * Increase in the sum of diameters of target lesion(s) identified at baseline to ≥ 20% and ≥ 5 mm from nadir * Unequivocal progression of non-target lesion(s) identified at baseline * Development of new lesion(s)

  2 years

Secondary Outcomes (9)

• Grade 4 Mucositis/Skin Reaction or Any Grade 5 Adverse Event Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment During the First Year

  during the first year

• Grade 4 Mucositis/Skin Reaction or Any Grade 5 Adverse Event Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment Occurring After the First Year

  after the first year, up to 24 months

• Patient Tolerability to Each Component (Neoadjuvant, Concurrent and Maintenance Part) of the Protocol Treatment Regimen

  2 year

• Other ≥ Grade 3 Adverse Events

  2 year

• Death During or Within 30 Days of Discontinuation of Protocol Treatment

  during or within 30 days

Study Arms (1)

pembrolizumab

EXPERIMENTAL

Total 51 weeks for 17 doses of pembrolizumab: * Neoadjuvant pembrolizumab-chemotherapy: 6 weeks (2 doses of pembrolizumab) * Concurrent pembrolizumab-chemoradiation: 9 weeks (3 doses of pembrolizumab * Maintenance pembrolizumab: 36 weeks (12 doses of pembrolizumab)

Drug: Pembrolizumab

Interventions

Pembrolizumab DRUG

200mg every 3 weeks infusion

Also known as: Concurrent Chemoradiation

pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of nasopharyngeal carcinoma (from primary lesion and/or lymph nodes) of WHO type II-III histology type will be enrolled in this study.
• Tumor confirmed EBV positive by EBER ISH assay
• AJCC 8th edition Stage IVA (i.e any T4 or any N3) based on the following diagnostic workup:
• Evaluation of tumor extent with MRI of the nasopharynx and neck. If MRI is medically contraindicated, CT scan with
• ≤ 3 mm and intravenous contrast is acceptable.
• Distant metastasis staging:
• i. CT scan with contrast of the chest, abdomen, and pelvis or a total body PET/CT scan; ii. Bone scan, if a PET/CT scan is not performed.
• A male participant must agree to use contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 120 days plus an additional 120 days (a spermatogenesis cycle) for study treatments with evidence of genotoxicity at any dose after the last dose of study treatment and refrain from donating sperm during this period.
• A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:
• Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR
• A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 120 days plus 30 days (a menstruation cycle) for study treatments with risk of genotoxicity after the last dose of study treatment.
• The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
• Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue. Note: If submitting unstained cut slides, newly cut slides should be submitted to the testing laboratory within 14 days from the date slides are cut.
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the date of allocation/randomization.
• Have adequate organ function as defined in the following table (Table 1). Specimens must be collected within 10 days prior to the start of study treatment.

You may not qualify if:

• A WOCBP who has a positive urine pregnancy test within 72 hours prior to first dosing (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
• Note: in the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for subject to start receiving study medication.
• Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
• Has received any prior systemic anti-cancer therapy including investigational agents.
• Has received any prior radiotherapy.
• Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
• Has a known additional malignancy. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
• Has known active CNS metastases and/or carcinomatous meningitis.
• Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
• Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
• Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
• Has an active infection requiring systemic therapy.
• Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is required unless mandated by local health authority.
• Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or known active Hepatitis C virus (defined as HCV RNA \[qualitative\] is detected) infection. Subjects who have been treated and now have a viral load that is undetectable are eligible.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (2)

Department of Clinical Oncology, Prince of Wales Hospital

Hong Kong, Hong Kong

Location

National Cancer Centre of Singapore

Singapore, Singapore

Location

MeSH Terms

Interventions

pembrolizumab

Results Point of Contact

• Title: Dr. Edwin Pun HUI
• Organization: The Chinese University of Hong Kong

p_hui@clo.cuhk.edu.hk

3505 2145

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: November 8, 2018
• Study Start: May 3, 2019
• Primary Completion: January 25, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 24, 2025
• Results First Posted: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1); HK (1)