Nasopharyngeal CarcinomaPhase 2/3NCT05576272

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

A Phase 2/3 study testing QL1706, Carrelizumab and Gemcitabine in people with Nasopharyngeal Carcinoma, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Nasopharyngeal Carcinoma
What is being tested?: QL1706, Carrelizumab and Gemcitabine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 460 participants
Where: 1 siteChina
Study dates: 19 May 2022to 30 Dec 2024
Phase: Phase 2/3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Sun Yat-sen University Cancer Center
Guangzhou, Guangzhou, 510060

Other trials in China

About this study

Official title: 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

Read the detailed description

The first part is a phase II, single-arm study with an introductory safety phase, which is planned to enroll 30 subjects with nasopharyngeal carcinoma treated with first-line QL1706 in combination with gemcitabine and cisplatin. The primary objective of the first part is to evaluate the safety and tolerability of QL1706 combined with gemcitabine and cisplatin in the first-line treatment of patients with recurrent or metastatic nasopharyngeal carcinoma.

The second part is a phase III randomized, controlled study. The study plans to enroll 430 subjects, who will be randomized in a 1:1 ratio to a trial group of QL1706 in combination with gemcitabine and cisplatin and a control group of carrilizumab in combination with gemcitabine and cisplatin. The primary objective of the second part was to compare the effectiveness of QL1706 with that of carrilizumab combined with gemcitabine and cisplatin, respectively, in the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma.

Conditions: Nasopharyngeal Carcinoma
Being tested: QL1706, Carrelizumab, Gemcitabine, Cisplatin
Medical subject headings: Nasopharyngeal Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

QL1706Drug
5 mg/kg#D1#Q3W IV, 4-6 cycles
CarrelizumabDrug
200mg#D1#Q3W IV, 4-6 cycles
GemcitabineDrug
1000mg/m2#D1\&D8#Q3W IV, 4-6 cycles
CisplatinDrug
80mg/m2#D1#Q3W IV, 4-6 cycles

Study groups in NCT05576272
Study group	Role	What they receive
QL1706 Combined with Gemcitabine and Cisplatin	Experimental	Not described Receives: Drug: QL1706; Drug: Gemcitabine; Drug: Cisplatin
Carrilizumab Combined with Gemcitabine and Cisplatin	Active comparator	Not described Receives: Drug: Carrelizumab; Drug: Gemcitabine; Drug: Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression free survival (PFS) -BICR
The PFS assessed by Blinded independent central review (BICR)
Measured: 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
The PFS assessed by Investigator
Measured: 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)
The ORR assessed by BICR and Investigator
Measured: 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)
The DOR assessed by BICR and Investigator
Measured: 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)
The DCR assessed by BICR and Investigator
Measured: 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)
Overall survival
Measured: 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
12-month OS rate
12-month Overall survival rate
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 May 202230 Dec 2024

First posted12 Oct 2022
Study start19 May 2022
Primary completion30 Dec 2024 (estimated)
Study completion30 Dec 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 460 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05576272
Sponsor's protocol ID: QL1706-302
Status last verified: Nov 2023
First submitted: 30 Sep 2022
Last updated: 22 Nov 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Nasopharyngeal Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT05576272
Acronym / sponsor ID: QL1706-302
Conditions: Nasopharyngeal Carcinoma
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 460 participants (estimated)
Lead sponsor: Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 19 May 2022 (actual)
Primary completion: 30 Dec 2024 (estimated)
Study completion: 30 Dec 2024 (estimated)
First posted: 12 Oct 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
QL17065 mg/kg#D1#Q3W IV, 4-6 cycles	Drug	QL1706 Combined with Gemcitabine and Cisplatin
Carrelizumab200mg#D1#Q3W IV, 4-6 cycles	Drug	Carrilizumab Combined with Gemcitabine and Cisplatin
Gemcitabine1000mg/m2#D1\&D8#Q3W IV, 4-6 cycles	Drug	Carrilizumab Combined with Gemcitabine and Cisplatin, QL1706 Combined with Gemcitabine and Cisplatin
Cisplatin80mg/m2#D1#Q3W IV, 4-6 cycles	Drug	Carrilizumab Combined with Gemcitabine and Cisplatin, QL1706 Combined with Gemcitabine and Cisplatin

Primary outcome

Progression free survival (PFS) -BICR
Time frame: 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
The PFS assessed by Blinded independent central review (BICR)

6 secondary outcomes

PFS- Investigator
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
12-month OS rate
Time frame: 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

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
Individual participant dataSharing planned: No

Related trials for Nasopharyngeal Carcinoma

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RecruitingPhase 2
Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
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Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
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Not yet recruitingObservational study
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RecruitingPhase 1/2
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

li Zhang, Doctor principal investigator

Sun Yat-sen University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing QL1706, Carrelizumab and Gemcitabine in people with Nasopharyngeal Carcinoma, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (PFS) -BICR (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05576272.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.