AzTrials
AzTrials

Head and Neck Squamous Cell CarcinomaPhase 1NCT06109207

Neoadjuvant Camrelizumab With Dalpiciclib for Resectable Head and Neck Squamous Cell Carcinomas

A Phase 1 study testing Camrelizumab, Dalpiciclib 100mg and Dalpiciclib 150mg in people with Head and Neck Squamous Cell Carcinoma, run by West China Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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
Search all trials

Trial summary

The purpose of this study is to explore the safety and feasibility of anti-programmed cell death protein 1(PD-1) immunotherapy, Camrelizumab, combined with cyclin-dependent kinase 4/6 blockade, Dalpiciclib, as a new neoadjuvant treatment regimen for patients with resectable head and neck squamous cell carcinoma(HNSCC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Squamous Cell Carcinoma
What is being tested?
Camrelizumab, Dalpiciclib 100mg and Dalpiciclib 150mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteChina
Study dates
31 Oct 2023to 31 Oct 2025
Phase
Phase 1
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

  • Age 18 years or above.
  • Patients with pathologically confirmed HNSCC (except for nasopharyngeal carcinoma) and meet the following conditions:
  • were newly diagnosed and without distant metastasis;
  • were deemed surgically resectable evaluated by a head and neck surgeon;
  • were willing to undergo surgery.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Adequate organ and bone marrow function: absolute neutrophil count ≥ 1.5 × 10^9/L, hemoglobin ≥ 80 g/L, platelets ≥ 80 × 10^9/L;ALT, AST and ALP < 2.5× upper limit of normal (ULN), total bilirubin ≤ 2×ULN;albumin≥ 2.8 g/dL；creatinine clearance ≥ 60 ml/min；INR≤ 1.5；APTT≤ 1.5×ULN
  • Written informed consent.

Who cannot join

  • History of other malignancies (except for the history of malignant tumors that have been cured and have not recurred within 5 years, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, in situ cervical cancer, and gastrointestinal mucosal cancer, etc.）
  • Have an active autoimmune disease requiring systemic treatment or a documented history of clinically severe autoimmune disease.
  • Any history of allergic disease, or a sever hypersensitivity reaction to drugs, or allergy to the study drug components.
  • Any of prior therapy with:anti-PD-1, anti-PD-L1/2, anti-CTLA-4 antibody, anti-EGFR antibody or EGFR-TKIs； antitumor vaccine; any active vaccine against an infectious disease within 4 weeks prior to the first dose or planned during the study period; major surgery or serious trauma within 4 weeks before the first dose; toxicity from prior antitumor therapy has not recovered to ≤ CTCAE Version 5.0 ·Grade 1 or the level specified by the inclusion/exclusion criteria.
  • With serious medical diseases, such as grade II and above cardiac dysfunction (NYHA criteria), ischemic heart disease, supraventricular or ventricular arrhythmia, poorly controlled diabetes mellitus, poorly controlled hypertension, echocardiographic ejection fraction < 50%, etc.
  • With interstitial pneumonitis, non-infectious pneumonitis, active pulmonary tuberculosis, or history of pulmonary tuberculosis infection that were not controlled by treatment.
Show all 14Show fewer
  • With hyperthyroidism, or organic thyroid disease.
  • With active infection, or unexplained fever during the screening period or 48 hours before the first dose.
  • With active hepatitis B or C, or known history of positive HIV test, or acquired immunodeficiency syndrome.
  • History of a clear neurological or psychiatric disorder.
  • History of drug abuse or alcohol abuse.
  • Women who are pregnant or breastfeeding, or have a reproductive plan from the screening period to 3 months after the end of the study, or have sex without contraceptive measures, or are unwilling to take appropriate contraceptive measures.
  • Received any investigational drug within 4 weeks prior to the first dose, or concurrently enrolled in another clinical trial.
  • Any other factors that are not suitable for inclusion in this study judged by investigators.

Trial locations and contacts

1 site in 1 country.

Jin Zhou, MD.,PhD. contact

+8613880626596

zhoujin096@scu.edu.cn

Shangwei Sun contact

+8615291996883

sunshangwei@stu.scu.edu.cn

China1 site, 1 recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

    Jin Zhou, MD.,PhD., +8613880626596, zhoujin096@scu.edu.cn

    Shangwei Sun, +8615291996883, sunshangwei@stu.scu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: The Safety and Feasibility of Neoadjuvant Camrelizumab With Dalpiciclib for the Treatment of Resectable Head and Neck Squamous Cell Carcinoma：A Phase 1 Trial

The purpose of this study is to explore the safety and feasibility of anti-programmed cell death protein 1(PD-1) immunotherapy, Camrelizumab, combined with cyclin-dependent kinase 4/6 blockade, Dalpiciclib, as a new neoadjuvant treatment regimen for patients with resectable head and neck squamous cell carcinoma(HNSCC).

Read the detailed description

Head and Neck Squamous Cell Carcinoma (HNSCC) is the most common malignancies of the head and neck, accounting for 90% of head and neck cancer. The 5-year survival rate under standard treatment is only 50%. 70%~80% of first diagnosed patients already developed into locally advanced status (stage II-Iva). In recent years, the use of neoadjuvant therapy (NAC) followed by surgery or radiotherapy has been advocated because of its higher probability of local/regional failure and distant metastasis after treatment. TPF (Docetaxel + Cisplatin + Fluorouracil) regimen is considered as the standard regimen of induced chemotherapy for head and neck squamous cell carcinoma (especially in laryngeal cancer), which can significantly reduce the patient's distant metastasis rate and prolong overall survival (OS). However, the therapeutic effect of neoadjuvant therapy on head and neck squamous cell carcinoma has reached a bottleneck. In recent years, PD-1 inhibitors have achieved significant effects in the field of tumor therapy and have been approved for the treatment of various tumors including recurrent metastatic head and neck tumors. There are also several prospective clinical research attempting to combine ICB with targeted therapeutic drugs for neoadjuvant therapy of HNSCC. The efficacy and safety results show potential synergy between these drugs.

Recent preclinical studies have shown that CDK4/6 inhibitors promote efficacy of PD-1/PD-L1 inhibitors through tumor antigen presentation enhancing, suppressed proliferation of regulatory T (Treg) cells, effector T- cell activation enhancing, and induction of T- cell memory. The previous study confirmed that CDK4/6 inhibitor combined with ICB can be administered safely in patients with recurrent or metastatic head and neck squamous cell carcinoma(HNSCC) and non-small cell lung carcinoma(NSCC).

In summary, the investigators designed this study to explore the safety and efficacy of anti-PD1 immunotherapy, Camrelizumab, combined with CDK4/6 inhibitor, dalpiciclib, as a new neoadjuvant treatment regimen for patients with resectable HNSCC. It will also provide new ideas, strategies, and experimental evidence for the development of immunotherapy.

Being tested
Camrelizumab, Dalpiciclib 100mg, Dalpiciclib 150mg
Keywords
Head and Neck Squamous Cell Carcinoma, Neoadjuvant therapy, Immunotherapy, CDK4/6 inhibitor
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

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

  • CamrelizumabDrug

    Camrelizumab will be given at at a dose of 200 mg intravenously every three weeks on day 1 of a planned 21-day cycle, and two doses before surgery

  • Dalpiciclib 100mgDrug

    Dalpiciclib will be given at a dose of 100 mg every day orally with three weeks on and one week off. Four weeks is a cycle and it will be given for two cycles.

  • Dalpiciclib 150mgDrug

    Dalpiciclib will be given at a dose of 150 mg every day orally with three weeks on and one week off. Four weeks is a cycle and it will be given for two cycles.

Study groups in NCT06109207
Study groupRoleWhat they receive
Camrelizumab+Dalpiciclib(100mg) 3 patientsExperimentalCamrelizumab will be given at at a dose of 200 mg intravenously every three weeks on day 1 of a planned 21-day cycle, and two doses before surgery Dalpiciclib will be given at a dose of 100 mg every day orally with three weeks on and one week off. Four weeks is a cycle and it will be given for two cycles. For dalpiciclib, there is 2 dose levels, 100mg qd and 150 mg qd, and if no patients experience DLT on 100mg level, 150mg level will be administered.
Receives: Drug: Camrelizumab; Drug: Dalpiciclib 100mg
Camrelizumab+Dalpiciclib(150mg) 3 patientsExperimentalCamrelizumab will be given at at a dose of 200 mg intravenously every three weeks on day 1 of a planned 21-day cycle, and two doses before surgery Dalpiciclib will be given at a dose of 150 mg every day orally with three weeks on and one week off. Four weeks is a cycle and it will be given for two cycles. For dalpiciclib, there is 2 dose levels, 100mg qd and 150 mg qd, and if no patients experience DLT on 100mg level, 150mg level will be administered.
Receives: Drug: Camrelizumab; Drug: Dalpiciclib 150mg

What is being measured

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

  1. Safety of combination camrelizumab and dalpiciclib as assessed by number of participants who experience adverse events

    Number of participants who experience grade 1 or higher adverse events, as defined by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).

    Measured: Through the study completion, an average of 12 weeks

  2. Feasibility of combination camrelizumab and dalpiciclib as assessed by number of participants who experience adverse events

    Number of participants who experience grade 1 or higher adverse events, as defined by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).

    Measured: Through the study completion, an average of 12 weeks

Secondary outcomes (5)

  1. Maximum Tolerated Dose (MTD) as determined by number of participants with dose limiting toxicities (DLT)

    Maximum tolerated dose will be determined by the maximum dose at which the least number of participants experience dose-limiting toxicity. The dose limiting toxicity is defined using the Common Terminology Criteria for Adverse Events (CTCAE).

    Measured: Through the study completion, an average of 12 weeks

  2. Major Pathologic Response

    Major Pathologic Response (MPR) was defined as fewer than 10% viable tumor cells.

    Measured: Time of surgery

  3. Objective response rate (ORR)

    Proportion of participants with measurable disease at baseline and have been re-evaluated after at least 1 cycle of therapy with observed reduction in tumor burden as defined by RECIST and iRECIST criteria after 2 doses of Proportion of participants with measurable disease at baseline and have been re-evaluated after at least 1 cycle of therapy with observed reduction in tumor burden as defined by RECIST and iRECIST criteria after 2 doses of nivolumab and ipilimumab.

    Measured: Through the study completion, an average of 12 weeks

  4. Progression free survival(PFS)

    Proportion of participants who achieve progression free survival post treatment

    Measured: Up to 2 years

  5. Overall survival (OS)

    Proportion of participants who achieve survival post treatment

    Measured: Up to 2 years

Timeline

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

  1. First posted31 Oct 2023
  2. Study start31 Oct 2023
  3. Primary completion31 Oct 2024 (estimated)
  4. Study completion31 Oct 2025 (estimated)

Resources

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
6 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06109207
Sponsor's protocol ID
2023-1551
Status last verified
Jul 2024
First submitted
25 Oct 2023
Last updated
23 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023 Jan;73(1):17-48. doi: 10.3322/caac.21763.

    PubMed 36633525

  • Yin J, Yuan J, Li Y, Fang Y, Wang R, Jiao H, Tang H, Zhang S, Lin S, Su F, Gu J, Jiang T, Lin D, Huang Z, Du C, Wu K, Tan L, Zhou Q. Neoadjuvant adebrelimab in locally advanced resectable esophageal squamous cell carcinoma: a phase 1b trial. Nat Med. 2023 Aug;29(8):2068-2078. doi: 10.1038/s41591-023-02469-3. Epub 2023 Jul 24.

    PubMed 37488287

  • Solomon B, Callejo A, Bar J, Berchem G, Bazhenova L, Saintigny P, Wunder F, Raynaud J, Girard N, Lee JJ, Sulaiman R, Prouse B, Bresson C, Ventura H, Magidi S, Rubin E, Young B, Onn A, Leyland-Jones B, Schilsky RL, Lazar V, Felip E, Kurzrock R. A WIN Consortium phase I study exploring avelumab, palbociclib, and axitinib in advanced non-small cell lung cancer. Cancer Med. 2022 Jul;11(14):2790-2800. doi: 10.1002/cam4.4635. Epub 2022 Mar 20.

    PubMed 35307972

  • Dennis MJ, Sacco AG, Qi Y, Bykowski J, Pittman E, Chen R, Messer K, Cohen EEW, Gold KA. A phase I study of avelumab, palbociclib, and cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma. Oral Oncol. 2022 Dec;135:106219. doi: 10.1016/j.oraloncology.2022.106219. Epub 2022 Oct 21.

    PubMed 36279618

  • Mody MD, Rocco JW, Yom SS, Haddad RI, Saba NF. Head and neck cancer. Lancet. 2021 Dec 18;398(10318):2289-2299. doi: 10.1016/S0140-6736(21)01550-6. Epub 2021 Sep 22.

    PubMed 34562395

  • Vermorken JB, Mesia R, Rivera F, Remenar E, Kawecki A, Rottey S, Erfan J, Zabolotnyy D, Kienzer HR, Cupissol D, Peyrade F, Benasso M, Vynnychenko I, De Raucourt D, Bokemeyer C, Schueler A, Amellal N, Hitt R. Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med. 2008 Sep 11;359(11):1116-27. doi: 10.1056/NEJMoa0802656.

    PubMed 18784101

  • Ferris RL, Blumenschein G Jr, Fayette J, Guigay J, Colevas AD, Licitra L, Harrington K, Kasper S, Vokes EE, Even C, Worden F, Saba NF, Iglesias Docampo LC, Haddad R, Rordorf T, Kiyota N, Tahara M, Monga M, Lynch M, Geese WJ, Kopit J, Shaw JW, Gillison ML. Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck. N Engl J Med. 2016 Nov 10;375(19):1856-1867. doi: 10.1056/NEJMoa1602252. Epub 2016 Oct 8.

    PubMed 27718784

  • Saba NF, Steuer CE, Ekpenyong A, McCook-Veal A, Magliocca K, Patel M, Schmitt NC, Stokes W, Bates JE, Rudra S, Remick J, McDonald M, Abousaud M, Tan AC, Fadlullah MZH, Chaudhary R, Muzaffar J, Kirtane K, Liu Y, Chen GZ, Shin DM, Teng Y, Chung CH. Pembrolizumab and cabozantinib in recurrent metastatic head and neck squamous cell carcinoma: a phase 2 trial. Nat Med. 2023 Apr;29(4):880-887. doi: 10.1038/s41591-023-02275-x. Epub 2023 Apr 3.

    PubMed 37012550

  • Ju WT, Xia RH, Zhu DW, Dou SJ, Zhu GP, Dong MJ, Wang LZ, Sun Q, Zhao TC, Zhou ZH, Liang SY, Huang YY, Tang Y, Wu SC, Xia J, Chen SQ, Bai YZ, Li J, Zhu Q, Zhong LP. A pilot study of neoadjuvant combination of anti-PD-1 camrelizumab and VEGFR2 inhibitor apatinib for locally advanced resectable oral squamous cell carcinoma. Nat Commun. 2022 Sep 14;13(1):5378. doi: 10.1038/s41467-022-33080-8.

    PubMed 36104359

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Camrelizumab, Dalpiciclib 100mg and Dalpiciclib 150mg in people with Head and Neck Squamous Cell Carcinoma, run by West China Hospital 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 8 inclusion and 14 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 23 Jul 2024. 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 phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Contact Jin Zhou, MD.,PhD. (+8613880626596, zhoujin096@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of combination camrelizumab and dalpiciclib as assessed by number of participants who experience adverse events (time frame: Through the study completion, an average of 12 weeks). The study lists 2 primary outcomes in all. 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 NCT06109207, which also lists 9 linked publications.

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 23 Jul 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in