A Phase II/III Trial to Evaluate the Efficacy and Safety of QL1706 in Patients With Nasopharyngeal Carcinoma

NCT05576272 | Unknown Phase 2

• 1 other identifier: QL1706-302
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, open, multicenter phase II/III trial to compare the efficacy and safety of QL1706 and carrilizumab combined with gemcitabine and cisplatin in first-line treatment of recurrent or metastatic nasopharyngeal carcinoma.

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS) -BICR

  The PFS assessed by Blinded independent central review (BICR)

  From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months after the last QL1706 injection has been administered

Secondary Outcomes (6)

• PFS- Investigator

  From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months after the last QL1706 injection has been administered

• Objective remission rate (ORR)

  Every 6 weeks, from the date of enrollment until the date of the last time that tumor imaging and assessment of disease has been done, assessed up to 72 weeks

• Duration of remission (DOR)

  Every 6 weeks, from the date of enrollment until the date of the last time that tumor imaging and assessment of disease has been done, assessed up to 72 weeks

• Disease Control Rate (DCR)

  Every 6 weeks, from the date of enrollment until the date of the last time that tumor imaging and assessment of disease has been done, assessed up to 72 weeks

• Overall survival (OS)

  From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months after the last QL1706 injection has been administered

Study Arms (2)

QL1706 Combined with Gemcitabine and Cisplatin

EXPERIMENTAL

Drug: QL1706; Drug: Gemcitabine; Drug: Cisplatin

Carrilizumab Combined with Gemcitabine and Cisplatin

ACTIVE COMPARATOR

Drug: Carrelizumab; Drug: Gemcitabine; Drug: Cisplatin

Interventions

QL1706 DRUG

5 mg/kg#D1#Q3W IV, 4-6 cycles

QL1706 Combined with Gemcitabine and Cisplatin

Carrelizumab DRUG

200mg#D1#Q3W IV, 4-6 cycles

Carrilizumab Combined with Gemcitabine and Cisplatin

Gemcitabine DRUG

1000mg/m2#D1\&D8#Q3W IV, 4-6 cycles

Carrilizumab Combined with Gemcitabine and Cisplatin; QL1706 Combined with Gemcitabine and Cisplatin

Cisplatin DRUG

80mg/m2#D1#Q3W IV, 4-6 cycles

Carrilizumab Combined with Gemcitabine and Cisplatin; QL1706 Combined with Gemcitabine and Cisplatin

Eligibility Criteria

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

You may qualify if:

• The subject will participate voluntarily and sign the informed consent form.
• Age ≥ 18 years when signing the informed consent form, male or female.
• The Eastern Collaborative Oncology Group (ECOG) physical status score was 0 or 1.
• Expected survival ≥ 3 months.
• Patients with pathologically confirmed nasopharyngeal carcinoma.
• Patients with primary diagnosis of metastatic nasopharyngeal carcinoma \[stage IVb according to the American Joint Committee on Cancer AJCC staging system (8th edition)\] or patients with recurrent (including recurrent or metastatic) nasopharyngeal carcinoma who are not candidates for radical surgery or radiotherapy or other local treatment; and for recurrent or metastatic lesions must be untreated systemically: previously treated with neoadjuvant chemotherapy with curative intent, Patients with adjuvant chemotherapy, radiotherapy or radiotherapy must have had ≥ 6 months between the last chemotherapy and or radiotherapy and the time of disease recurrence and/or development of metastases.
• Patients have at least one imaging measurable lesion according to RECISTv1.1 evaluation criteria; for lesions that have received prior radiotherapy or other local treatment there must be evidence of definite progression of the lesion after the end of local treatment in order to be selected as a measurable lesion.
• Adequate organ function prior to first use of the experimental drug (no blood components, leukocyte-raising drugs, or platelet-raising drugs are allowed within 7 days prior to obtaining laboratory tests)
• Absolute neutrophil count ≥ 1.5 x 109/L.
• Platelet count ≥ 100×109/L.
• Hemoglobin ≥ 90 g/L.
• Serum albumin ≥ 28 g/L.
• Subjects (both female and male) agree to use effective contraception from the time they sign the informed consent until 180 days after the last use of the trial drug. Women who are not pregnant or breastfeeding from the time they sign informed consent until 180 days after the last use of the trial drug.

You may not qualify if:

• Presence of symptomatic central nervous system (CNS) metastases, soft meningeal metastases, or spinal cord compression due to metastases.
• Prior systemic anticancer treatment with approved drugs or trial drugs.
• End date of palliative radiotherapy targeting bone metastases or soft tissue, etc. ≤ 7 days from imaging of baseline tumor lesions
• Presence of carcinomatous meningitis prior to first study treatment
• Active autoimmune disease present within 2 years prior to the first administration of the investigational drug and requiring systemic systemic therapy. Subjects with relevant alternative therapy who are stable are allowed to be included.
• Disease requiring systemic treatment with corticosteroids (\>10 mg daily prednisone or equivalent) or other immunosuppressive drugs present within 2 weeks prior to first study treatment.
• At the investigator's discretion, have a serious concomitant condition that jeopardizes patient safety, or interferes with patient completion of the study, such as hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg) not controlled by two or more antihypertensive medications, or severe diabetes mellitus.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangzhou, 510060, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

camrelizumab; Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• li Zhang, Doctor

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2022
• First Posted: October 12, 2022
• Study Start: May 19, 2022
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)