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Combination Therapy for PD-1 Resistant Recurrent or Metastatic Nasopharyngeal Carcinoma: A Bayesian Adaptive Phase II Trial

ConditionRecurrent or Metastatic Nasopharyngeal Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMing-Yuan Chen

About this trial

This is a prospective, Bayesian adaptive, phase II clinical trial designed to evaluate the safety and efficacy of four treatment regimens in patients with recurrent (unamenable to local therapy) or metastatic nasopharyngeal carcinoma (NPC) who have failed after at least one prior platinum-containing standard regimen and anti-PD-1/PD-L1 therapy.

The four treatment arms include:

1. Ivonescimab monotherapy, 2. Ivonescimab combined with nimotuzumab, 3. Liposomal mitoxantrone plus anti-PD-1 antibody, and 4. Liposomal irinotecan plus S-1.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically and/or cytologically confirmed recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (either differentiated or undifferentiated subtype, corresponding to WHO type II or III).

Age between 18 and 70 years.

Performance Status (PS) score of 0 or 1.

Disease progression after prior platinum-based doublet chemotherapy.

Disqualifiers

Locoregional recurrent lesions that are amenable to definitive (curative) treatment, such as surgery.

Prior treatment with any regimen included in the study protocol.

Prior use of agents targeting the VEGF or VEGFR pathway.

Diagnosis and/or treatment of another malignancy within the past 5 years, with the exception of adequately treated carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situ.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ivonescimab

    Drug

    Ivonescimab 10 mg/kg via intravenous infusion, until the occurrence of intolerable toxicity, withdrawal of informed consent, initiation of new antitumor therapy, loss to follow-up, or death, whichever occurs first.

  • Nimotuzumab

    Drug

    Nimotuzumab 400 mg via intravenous infusion, Q3W, until the occurrence of intolerable toxicity, withdrawal of informed consent, initiation of new antitumor therapy, loss to follow-up, or death, whichever occurs first.

  • Irinotecan liposome

    Drug

    Irinotecan liposome 50mg/m2 via intravenous infusion, D1, D15, Q4W for up to 6 cycles or until intolerable toxicity, subject withdrawal of informed consent, diseases progression, initiation of new antitumor therapy, loss of follow-up, or death, whichever occurs first.

  • S-1

    Drug

    S-1, D1-D14, BID, p.o., (BSA \< 1.25 m2, 40 mg/dose; 1.25 m2 ⩽ BSA \< 1.5 m2, 50 mg/dose; BSA ⩾ 1.5 m2, 60mg/dose), Q4W for up to 6 cycles or until intolerable toxicity, subject withdrawal of informed consent, diseases progression, initiation of new antitumor therapy, loss of follow-up, or death, whichever occurs first.

  • Mitoxantrone Hydrochloride Liposome

    Drug

    Mitoxantrone hydrochloride liposome 20mg/m2 via intravenous infusion, Q3W for up to 8 cycles or until intolerable toxicity, subject withdrawal of informed consent, diseases progression, initiation of new antitumor therapy, loss of follow-up, or death, whichever occurs first

  • PD-1 Inhibitors

    Drug

    PD-1 blockade (comprising tislelizumab \<200 mg/cycle\>, carrellimab \<200 mg/cycle\>, or toripalimab \<240 mg/cycle\>) , Q3W for two years, or until intolerable toxicity, subject withdrawal of informed consent, diseases progression, initiation of new antitumor therapy, loss of follow-up, or death, whichever occurs first.

Treatment groups

208 Participants
are divided into 4 treatment groups
Group A: Ivonescimab MonotherapyExperimental treatment 1 intervention
Group B: Ivonescimab plus NimotuzumabExperimental treatment 2 interventions
Group C: Mitoxantrone Plus PD-1 InhibitorExperimental treatment 2 interventions
Group D: Irinotecan plus S-1Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Overall Response Rate (ORR)

Defined as the proportion of patients whose tumors shrink to complete response (CR) or partial response (PR) and remain for a certain period of time according to RECIST 1.1

Time frame
1 year

Secondary outcomes

1

Progression-free Survival (PFS)

PFS is defined as the time interval from randomization to the observation of disease progression or death from any cause

Time frame
1 year
2

Overall Survival (OS)

OS is defined as the time interval from randomization to death from any cause

Time frame
1 year
3

Duration of Response (DOR)

DOR is defined as time from the first assessment of CR or PR until the date of the first occurrence of PD, or until the date of death

Time frame
1 year
4

Disease Control Rate (DCR)

DCR is defined as the percentage of patients who have achieved CR, PR and SD to a therapeutic intervention

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ming-Yuan Chen

Lead sponsor

Sun Yat-sen University

Sponsor institution

Source ClinicalTrials.gov
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