Nivolumab in Children and Adults With Nasopharyngeal Carcinoma

Sponsor
German Society for Pediatric Oncology and Hematology GPOH gGmbH
Study ID
NCT06019130
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Nasopharyngeal Cancer
  • Nasopharyngeal Carcinoma
  • Nasopharyngeal Neoplasms
  • Nasopharynx Cancer

Eligibility Criteria

Sex
ALL
Age
3 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Nivolumab during induction chemotherapy in all groups and during radiochemotherapy in patients with SD or PD after induction or metastases
  • Cisplatin — DRUG
    Cisplatin during induction chemotherapy and during radiochemotherapy in all groups
  • 5-Fluorouracil — DRUG
    5-Fluoruracil during induction chemotherapy in all groups except of adults \> 25 years with metastatic disease at diagnosis
  • Gemcitabine — DRUG
    Gemcitabine during induction chemotherapy in patients \> 25 years with metastatic disease at diagnosis
  • Radiotherapy — RADIATION
    After induction therapy in all patients
  • Interferon beta-1a — DRUG
    In patients \< 26 years after end of radiochemotherapy for 6 months
  • MRI — PROCEDURE
    At diagnosis and 17 to 22 days after the beginning of cycle 3 of induction therapy
  • PET — PROCEDURE
    At diagnosis and 17 to 22 days after the beginning of cycle 3 of induction therapy, either as PET-CT or PET-MRI
  • Patient-Reported Outcomes — BEHAVIORAL
    For all patients at baseline, before radiochemotherapy, at day 100, and 2 years after enrolment

Study Details

The purpose of this study is to assess whether the addition of the immune checkpoint inhibitor Nivolumab to induction chemotherapy will increase the percentage of patients with a complete response on MRI and PET after 3 cycles of induction therapy.

Key Dates

Start date
Jan 10, 2023
Status verified
May 2024
Primary completion
Jan 9, 2026
Completion
Jan 9, 2028

Study Design

Enrollment
57 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Patients < 26 years with non-metastatic disease with CR or PR after induction therapy
    Participants receive Nivolumab (4.5 mg/kg BW (max. 360 mg) every three weeks) during induction chemotherapy for a total of 3 doses, starting on day 1 of cycle 1 of induction standard chemotherapy with cisplatin 100 mg/m2 on day 1, plus 5-fluorouracil 1,000 mg/m2/d from day 1-5. After induction therapy patients will undergo standard radiochemotherapy. Primary PTV1 including elective irradiated LN-levels, will be 45Gy, with a boost ad 59.4Gy in patients with PR or a reduced boost at 54Gy in patients with CR. Cisplatin will be administered at 3x20mg/m2 in the first and last week of radiotherapy, each. Radiochemotherapy is followed by maintenance therapy with recombinant interferon-ß1a at 3x6Mio IU/week s.c. for 6 months.
  • Experimental: Patients < 26 y with no metastases and SD or PD after induction therapy or patients with metastases
    Participants receive Nivolumab (4.5 mg/kg BW (max. 360 mg) every three weeks) during induction chemotherapy for a total of 3 doses, starting on day 1 of cycle 1 of induction standard chemotherapy with cisplatin 100 mg/m2 on day 1, plus 5-fluorouracil 1,000 mg/m2/d from day 1-5. Patients with metastases responding to induction therapy may have a fourth cycle of induction therapy, including a fourth dose of Nivolumab. After induction therapy patients will undergo standard radiochemotherapy. Primary PTV1 including elective irradiated LN-levels, will be 45Gy, with a boost ad 59.4Gy. Cisplatin will be administered at 3x20mg/m2 in the first and last week of radiotherapy, each. Nivolumab (4.5 mg/kg BW (max. 360 mg) every three weeks) will be continued during radiochemotherapy, adding a total of 3 further doses of Nivolumab. Radiochemotherapy is followed by maintenance therapy with recombinant interferon-ß1a at 3x6Mio IU/week s.c. for 6 months.
  • Experimental: Patients >25 years with non-metastatic disease with CR or PR after induction therapy
    Participants receive Nivolumab (4.5 mg/kg BW (max. 360 mg) every three weeks) during induction chemotherapy for a total of 3 doses, starting on day 1 of cycle 1 of induction standard chemotherapy with cisplatin 100 mg/m2 on day 1, plus 5-fluorouracil 1,000 mg/m2/d from day 1-5. After induction therapy patients will undergo standard radiochemotherapy as outlined in current international guidelines (e.g. NCCN, ESMO).
  • Experimental: Patients > 25 years with non-metastatic disease with SD or PD after induction therapy
    Participants receive Nivolumab (4.5 mg/kg BW (max. 360 mg) every three weeks) during induction chemotherapy for a total of 3 doses, starting on day 1 of cycle 1 of induction standard chemotherapy with cisplatin 100 mg/m2 on day 1, plus 5-fluorouracil 1,000 mg/m2/d from day 1-5. After induction therapy patients will undergo standard radiochemotherapy as outlined in current international guidelines (e.g. NCCN, ESMO). Nivolumab (4.5 mg/kg BW (max. 360 mg) every three weeks) will be continued during radiochemotherapy, adding a total of 3 further doses of Nivolumab.
  • Experimental: Patients > 25 years with metastatic disease at diagnosis
    Participants receive Nivolumab (4.5 mg/kg BW (max. 360 mg) every three weeks) during induction chemotherapy for a total of 3 doses, starting on day 1 of cycle 1 of induction standard chemotherapy with cisplatin 80 mg/m2 on day 1, plus gemcitabine 1,000 mg/m2/d on day 1 and day 8, respectively. Patients responding to induction therapy may have a fourth cycle of induction therapy, including a fourth dose of Nivolumab. After induction therapy patients will undergo standard radiochemotherapy as outlined in current international guidelines (e.g. NCCN, ESMO). Nivolumab (4.5 mg/kg BW (max. 360 mg) every three weeks) will be continued during radiochemotherapy, adding a total of 3 further doses of Nivolumab.

Primary Outcome Measure

Complete remission rate after induction therapy [ Time Frame: MRI and PET will be done 17-22 days after start of induction therapy cycle 3 (each cycle is 21 days) ]

Central Contacts

Related Studies