Nasopharyngeal CarcinomaPhase 2NCT04830267
The Efficacy of Camrelizumab Plus Stereotactic Body Radiotherapy in R/M NPC
A Phase 2 study testing Camrelizumab and Stereotactic body radiotherapy in people with Nasopharyngeal Carcinoma, run by Chongqing University Cancer Hospital at 3 sites in China.
Trial summary
Camrelizumab is an antibody targeting programmed death receptor 1 (PD-1) and its ligand programmed death-ligand 1 (PD- L1) that is designed to boost the immune system. It does this by allowing immune cells to fight the cancer. 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?
- Camrelizumab and Stereotactic body radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 3 sitesChina
- Study dates
- 1 Mar 2021to 1 Aug 2026
- Phase
- Phase 2
- 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
- Signed Written Informed Consent
- Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines.
- Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other study obligations.
- Target Population:
- Males and females ≥ 18 years of age Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. Histologically confirmed metastatic or recurrent nasopharyngeal carcinoma.
- Subjects must have at least two lesions:
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- At least one lesion must be safely amenable to irradiation. This can be a lesion that was previously irradiated as long as prior radiation was at least 6 months prior to projected first fraction of SBRT and as long as reirradiation dose constraints are being met.
- A separate, not-to-be-irradiated lesion measurable by CT or MRI per RECIST 1.1 criteria.
- The peripheral blood EBV DNA copy number can be obtained.
- Prior palliative or curative radiotherapy must be completed at least 14 days prior to randomization.
- Immunosuppressive doses of systemic medication, such as steroids or absorbed topical steroids (doses >10mg/day prednisone or equivalent) must be discontinued at least 14 days prior to Camrelizumab administration.
- Screening laboratory values must meet the following criteria (using CTCAE v4.0) and should be obtained within 28 days prior to randomization:
- WBC ≥ 2 K/microliter Neutrophils ≥ 1.5 K/microliter Platelets ≥ 100 K/microliter Hemoglobin ≥ 9.0 g/deciliter Serum Creatinine ≤ 1.5 x ULN or creatinine clearance > 40ml/min using the Cockcroft-Gault formula.
- Female CrCl = (140 - age in years) x weight in kg x 0.85 72 x serum creatinine in mg/dL Male CrCl = (140 - age in years) x weight in kg x 1.00 72 x serum creatinine in mg/dL AST/ALT ≤ 3 x ULN Total bilirubin <1.5 x ULN (except subjects with Gilbert Syndrome who can have total bilirubin <3.0 mg/deciliter).
- Subjects must have a resting baseline O2 saturation by pulse oximetry of >=92% at rest.
- Reproductive Status:
- Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 28 days prior to randomization.
- Women must not be breastfeeding Women of childbearing potential must agree to follow instructions for method(s) of contraception from time of enrollment for the duration of treatment with Camrelizumab plus 5 half- lives plus 30 days for a total of 23 weeks post treatment completion.
- Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving Camrelizumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product.
- Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men do not require contraception.
- Azoospermic males and women of childbearing potential who are continuously not heterosexually active are exempt from contraceptive requirements. However, they still must have a pregnancy test.
Who cannot join
- Target Disease Exceptions:
- Active brain metastases (untreated brain metastases or growth on imaging as defined below) or leptomeningeal disease are not allowed. Subjects with brain metastases are eligible if these have been treated and there is no MRI (or CT if MRI contraindicated) evidence of progression for at least 8 weeks after treatment for these metastases is complete and within 28 days prior to first study treatment.
- Medical History and Concurrent Diseases:
- Any medical disorder that, in the opinion of the investigator, might increase the risk associated with study participation or interferes with the interpretation of study results.
- Prior active malignancy within the previous 3 years except for locally curable cancers such as basal or squamous skin cancer, superficial bladder, low risk prostate cancer, breast, or cervix cancer. If other prior malignancy was active within prior 3 years, enrollment requires approval of a principal investigator.
- Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration should be excluded. Inhaled or topical steroids and adrenal replacement doses >10mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
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- Physical and Laboratory Test Findings:
- Positive test for hepatitis B virus surface antigen or hepatitis C virus ribonucleic acid indicating acute or chronic infection.
- Known history of testing positive for HIV or known AIDS. Any grade 4 laboratory abnormalities. Allergies and Adverse Drug Reaction History of allergy to Camrelizumab components History of severe hypersensitivity reaction to any monoclonal antibody.
- Prohibited or Restricted Treatments:
- The following medications are prohibited during the study:
- Immunosuppressive agents (except to treat a drug-related adverse event). Systemic corticosteroids > 10 mg daily prednisone equivalent save for exclusion outlined in the below paragraphs.
- Any concurrent chemotherapy, hormonal therapy, immunotherapy, or investigational agents for treatment of cancer.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030
Jiangdong Sui, Ph.D, M. D., 13594910011, jiangdong.sui@cqu.edu.cn
Ying Wang, Ph.D, M. D., 13996412826, yingwang197011@163.com
- Recruiting
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 646000
Kun He, 0830-3165273, xnydhh@163.com
- Recruiting
Chongqing University Three Gorges Hospital
Wanzhou, Chongqing Municipality, 404100
Chuan Zhu, M.D, 13983505825, 981149098@qq.com
About this study
Official title: A Phase II Randomized Trial of Camrelizumab With Stereotactic Body Radiotherapy Versus Camrelizumab Alone in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
Camrelizumab is an antibody targeting programmed death receptor 1 (PD-1) and its ligand programmed death-ligand 1 (PD- L1) that is designed to boost the immune system. It does this by allowing immune cells to fight the cancer. Stereotactic body radiotherapy is a potential immunostimulatory therapy that may amplify antitumor response when combined with camrelizumab.
Read the detailed description
All eligible patients from 3 hospitals will be equally randomized between the 2 following treatment groups:
Standard treatment group: Camrelizumab 200mg IV every 2 weeks. Experimental group: Stereotactic body radiotherapy 27Gy/3F and Camrelizumab 200mg IV every 2 weeks.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Camrelizumab, Stereotactic body radiotherapy
- Keywords
- Camrelizumab, Stereotactic body radiotherapy, R/M NPC, Best overall response
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamrelizumabDrug
Also called Anti-PD-1 antibody
Camrelizumab 200mg IV starting day 1 and then every 2 weeks thereafter. Treatment with Camrelizumab will continue until progression or unacceptable toxicity.
Stereotactic body radiotherapyRadiation
Also called SBRT
Image guided, stereotactic body radiotherapy (27 Gy over 3 fractions given every other day) to a single lesion to start by study day 14 (study day 1 is day of first dose of Camrelizumab).
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab alone | Active comparator | Camrelizumab 200mg IV every 2 weeks Receives: Drug: Camrelizumab |
| Stereotactic body radiotherapy plus Camrelizumab | Experimental | Stereotactic body radiotherapy 27Gy/3F and Camrelizumab 200mg IV every 2 weeks Receives: Drug: Camrelizumab; Radiation: Stereotactic body radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best overall response (BOR)
As determined by the investigator using RECIST 1.1 criteria between patients receiving Camrelizumab and stereotactic body radiotherapy and those receiving Camrelizumab alone. BOR rate is defined as the number of patients randomized to a given arm with a best overall response of complete response (CR) or partial response (PR) of non-irradiated lesions divided by the total number of patients randomized to the given arm. In order to ascertain this endpoint, efforts will be made so that patients will be followed for 96 weeks or until progression of disease (and treatment cessation), whichever comes first. At each time-point, subjects should have CT/MR of neck, chest, abdomen, and pelvis with contrast.
Measured: Time Frame: 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start1 Mar 2021
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing University Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Wang, Chongqing University Cancer Hospital
- Investigators
- Ying Wang, Ph.D, M.D., Principal investigator, Chongqing University Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04830267
- Sponsor's protocol ID
- Camresbrt
- Status last verified
- Mar 2024
- First submitted
- 31 Mar 2021
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McDermott DF, Shah R, Gupte-Singh K, Sabater J, Luo L, Botteman M, Rao S, Regan MM, Atkins M. Quality-adjusted survival of nivolumab plus ipilimumab or nivolumab alone versus ipilimumab alone among treatment-naive patients with advanced melanoma: a quality-adjusted time without symptoms or toxicity (Q-TWiST) analysis. Qual Life Res. 2019 Jan;28(1):109-119. doi: 10.1007/s11136-018-1984-3. Epub 2018 Sep 6.
PubMed 30191365Janjigian YY, Bendell J, Calvo E, Kim JW, Ascierto PA, Sharma P, Ott PA, Peltola K, Jaeger D, Evans J, de Braud F, Chau I, Harbison CT, Dorange C, Tschaika M, Le DT. CheckMate-032 Study: Efficacy and Safety of Nivolumab and Nivolumab Plus Ipilimumab in Patients With Metastatic Esophagogastric Cancer. J Clin Oncol. 2018 Oct 1;36(28):2836-2844. doi: 10.1200/JCO.2017.76.6212. Epub 2018 Aug 15.
PubMed 30110194Fang W, Yang Y, Ma Y, Hong S, Lin L, He X, Xiong J, Li P, Zhao H, Huang Y, Zhang Y, Chen L, Zhou N, Zhao Y, Hou X, Yang Q, Zhang L. Camrelizumab (SHR-1210) alone or in combination with gemcitabine plus cisplatin for nasopharyngeal carcinoma: results from two single-arm, phase 1 trials. Lancet Oncol. 2018 Oct;19(10):1338-1350. doi: 10.1016/S1470-2045(18)30495-9. Epub 2018 Sep 10.
PubMed 30213452Burnette BC, Liang H, Lee Y, Chlewicki L, Khodarev NN, Weichselbaum RR, Fu YX, Auh SL. The efficacy of radiotherapy relies upon induction of type i interferon-dependent innate and adaptive immunity. Cancer Res. 2011 Apr 1;71(7):2488-96. doi: 10.1158/0008-5472.CAN-10-2820. Epub 2011 Feb 7.
PubMed 21300764Sharma A, Bode B, Studer G, Moch H, Okoniewski M, Knuth A, von Boehmer L, van den Broek M. Radiotherapy of human sarcoma promotes an intratumoral immune effector signature. Clin Cancer Res. 2013 Sep 1;19(17):4843-53. doi: 10.1158/1078-0432.CCR-13-0352. Epub 2013 Jul 16.
PubMed 23861514Deng L, Liang H, Burnette B, Beckett M, Darga T, Weichselbaum RR, Fu YX. Irradiation and anti-PD-L1 treatment synergistically promote antitumor immunity in mice. J Clin Invest. 2014 Feb;124(2):687-95. doi: 10.1172/JCI67313. Epub 2014 Jan 2.
PubMed 24382348Postow MA, Callahan MK, Barker CA, Yamada Y, Yuan J, Kitano S, Mu Z, Rasalan T, Adamow M, Ritter E, Sedrak C, Jungbluth AA, Chua R, Yang AS, Roman RA, Rosner S, Benson B, Allison JP, Lesokhin AM, Gnjatic S, Wolchok JD. Immunologic correlates of the abscopal effect in a patient with melanoma. N Engl J Med. 2012 Mar 8;366(10):925-31. doi: 10.1056/NEJMoa1112824.
PubMed 22397654Golden EB, Demaria S, Schiff PB, Chachoua A, Formenti SC. An abscopal response to radiation and ipilimumab in a patient with metastatic non-small cell lung cancer. Cancer Immunol Res. 2013 Dec;1(6):365-72. doi: 10.1158/2326-6066.CIR-13-0115.
PubMed 24563870Zandberg DP, Strome SE. The role of the PD-L1:PD-1 pathway in squamous cell carcinoma of the head and neck. Oral Oncol. 2014 Jul;50(7):627-32. doi: 10.1016/j.oraloncology.2014.04.003. Epub 2014 May 10.
PubMed 24819861McBride S, Sherman E, Tsai CJ, Baxi S, Aghalar J, Eng J, Zhi WI, McFarland D, Michel LS, Young R, Lefkowitz R, Spielsinger D, Zhang Z, Flynn J, Dunn L, Ho A, Riaz N, Pfister D, Lee N. Randomized Phase II Trial of Nivolumab With Stereotactic Body Radiotherapy Versus Nivolumab Alone in Metastatic Head and Neck Squamous Cell Carcinoma. J Clin Oncol. 2021 Jan 1;39(1):30-37. doi: 10.1200/JCO.20.00290. Epub 2020 Aug 21.
PubMed 32822275
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Trial of Camrelizumab With Stereotactic Body Radiotherapy Versus Camrelizumab Alone in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT04830267
- Acronym / sponsor ID
- Camresbrt
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Camrelizumab, Stereotactic body radiotherapy, R/M NPC, Best overall response
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Chongqing University Cancer HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 5 Apr 2021 (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.
Camrelizumab is an antibody targeting programmed death receptor 1 (PD-1) and its ligand programmed death-ligand 1 (PD- L1) that is designed to boost the immune system. It does this by allowing immune cells to fight the cancer. Stereotactic body radiotherapy is a potential immunostimulatory therapy that may amplify antitumor response when combined with camrelizumab.
Detailed description
All eligible patients from 3 hospitals will be equally randomized between the 2 following treatment groups:
Standard treatment group: Camrelizumab 200mg IV every 2 weeks. Experimental group: Stereotactic body radiotherapy 27Gy/3F and Camrelizumab 200mg IV every 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab alone | Active comparator | Drug: CamrelizumabCamrelizumab 200mg IV every 2 weeks |
| Stereotactic body radiotherapy plus Camrelizumab | Experimental | Drug: Camrelizumab, Radiation: Stereotactic body radiotherapyStereotactic body radiotherapy 27Gy/3F and Camrelizumab 200mg IV every 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Signed Written Informed Consent
- Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines.
- Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other study obligations.
- Target Population:
- Males and females ≥ 18 years of age Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. Histologically confirmed metastatic or recurrent nasopharyngeal carcinoma.
Key exclusion criteria (13 listed)
- Target Disease Exceptions:
- Active brain metastases (untreated brain metastases or growth on imaging as defined below) or leptomeningeal disease are not allowed. Subjects with brain metastases are eligible if these have been treated and there is no MRI (or CT if MRI contraindicated) evidence of progression for at least 8 weeks after treatment for these metastases is complete and within 28 days prior to first study treatment.
- Medical History and Concurrent Diseases:
- Any medical disorder that, in the opinion of the investigator, might increase the risk associated with study participation or interferes with the interpretation of study results.
- Prior active malignancy within the previous 3 years except for locally curable cancers such as basal or squamous skin cancer, superficial bladder, low risk prostate cancer, breast, or cervix cancer. If other prior malignancy was active within prior 3 years, enrollment requires approval of a principal investigator.
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 |
|---|---|---|
| CamrelizumabAlso: Anti-PD-1 antibodyCamrelizumab 200mg IV starting day 1 and then every 2 weeks thereafter. Treatment with Camrelizumab will continue until progression or unacceptable toxicity. | Drug | Camrelizumab alone, Stereotactic body radiotherapy plus Camrelizumab |
| Stereotactic body radiotherapyAlso: SBRTImage guided, stereotactic body radiotherapy (27 Gy over 3 fractions given every other day) to a single lesion to start by study day 14 (study day 1 is day of first dose of Camrelizumab). | Radiation | Stereotactic body radiotherapy plus Camrelizumab |
Primary outcome
Best overall response (BOR)
Time frame: Time Frame: 96 weeks
As determined by the investigator using RECIST 1.1 criteria between patients receiving Camrelizumab and stereotactic body radiotherapy and those receiving Camrelizumab alone. BOR rate is defined as the number of patients randomized to a given arm with a best overall response of complete response (CR) or partial response (PR) of non-irradiated lesions divided by the total number of patients randomized to the given arm. In order to ascertain this endpoint, efforts will be made so that patients will be followed for 96 weeks or until progression of disease (and treatment cessation), whichever comes first. At each time-point, subjects should have CT/MR of neck, chest, abdomen, and pelvis with contrast.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Background: PubMed 30191365McDermott DF, Shah R, Gupte-Singh K, Sabater J, Luo L, Botteman M, Rao S, Regan MM, Atkins M. Quality-adjusted survival of nivolumab plus ipilimumab or nivolumab alone versus ipilimumab alone among treatment-naive patients with advanced melanoma: a quality-adjusted time without symptoms or toxicity (Q-TWiST) analysis. Qual Life Res. 2019 Jan;28(1):109-119. doi: 10.1007/s11136-018-1984-3. Epub 2018 Sep 6.
- Background: PubMed 30110194Janjigian YY, Bendell J, Calvo E, Kim JW, Ascierto PA, Sharma P, Ott PA, Peltola K, Jaeger D, Evans J, de Braud F, Chau I, Harbison CT, Dorange C, Tschaika M, Le DT. CheckMate-032 Study: Efficacy and Safety of Nivolumab and Nivolumab Plus Ipilimumab in Patients With Metastatic Esophagogastric Cancer. J Clin Oncol. 2018 Oct 1;36(28):2836-2844. doi: 10.1200/JCO.2017.76.6212. Epub 2018 Aug 15.
- Background: PubMed 30213452Fang W, Yang Y, Ma Y, Hong S, Lin L, He X, Xiong J, Li P, Zhao H, Huang Y, Zhang Y, Chen L, Zhou N, Zhao Y, Hou X, Yang Q, Zhang L. Camrelizumab (SHR-1210) alone or in combination with gemcitabine plus cisplatin for nasopharyngeal carcinoma: results from two single-arm, phase 1 trials. Lancet Oncol. 2018 Oct;19(10):1338-1350. doi: 10.1016/S1470-2045(18)30495-9. Epub 2018 Sep 10.
- Background: PubMed 21300764Burnette BC, Liang H, Lee Y, Chlewicki L, Khodarev NN, Weichselbaum RR, Fu YX, Auh SL. The efficacy of radiotherapy relies upon induction of type i interferon-dependent innate and adaptive immunity. Cancer Res. 2011 Apr 1;71(7):2488-96. doi: 10.1158/0008-5472.CAN-10-2820. Epub 2011 Feb 7.
- Background: PubMed 23861514Sharma A, Bode B, Studer G, Moch H, Okoniewski M, Knuth A, von Boehmer L, van den Broek M. Radiotherapy of human sarcoma promotes an intratumoral immune effector signature. Clin Cancer Res. 2013 Sep 1;19(17):4843-53. doi: 10.1158/1078-0432.CCR-13-0352. Epub 2013 Jul 16.
- Background: PubMed 24382348Deng L, Liang H, Burnette B, Beckett M, Darga T, Weichselbaum RR, Fu YX. Irradiation and anti-PD-L1 treatment synergistically promote antitumor immunity in mice. J Clin Invest. 2014 Feb;124(2):687-95. doi: 10.1172/JCI67313. Epub 2014 Jan 2.
- Background: PubMed 22397654Postow MA, Callahan MK, Barker CA, Yamada Y, Yuan J, Kitano S, Mu Z, Rasalan T, Adamow M, Ritter E, Sedrak C, Jungbluth AA, Chua R, Yang AS, Roman RA, Rosner S, Benson B, Allison JP, Lesokhin AM, Gnjatic S, Wolchok JD. Immunologic correlates of the abscopal effect in a patient with melanoma. N Engl J Med. 2012 Mar 8;366(10):925-31. doi: 10.1056/NEJMoa1112824.
- Background: PubMed 24563870Golden EB, Demaria S, Schiff PB, Chachoua A, Formenti SC. An abscopal response to radiation and ipilimumab in a patient with metastatic non-small cell lung cancer. Cancer Immunol Res. 2013 Dec;1(6):365-72. doi: 10.1158/2326-6066.CIR-13-0115.
- Background: PubMed 24819861Zandberg DP, Strome SE. The role of the PD-L1:PD-1 pathway in squamous cell carcinoma of the head and neck. Oral Oncol. 2014 Jul;50(7):627-32. doi: 10.1016/j.oraloncology.2014.04.003. Epub 2014 May 10.
- Background: PubMed 32822275McBride S, Sherman E, Tsai CJ, Baxi S, Aghalar J, Eng J, Zhi WI, McFarland D, Michel LS, Young R, Lefkowitz R, Spielsinger D, Zhang Z, Flynn J, Dunn L, Ho A, Riaz N, Pfister D, Lee N. Randomized Phase II Trial of Nivolumab With Stereotactic Body Radiotherapy Versus Nivolumab Alone in Metastatic Head and Neck Squamous Cell Carcinoma. J Clin Oncol. 2021 Jan 1;39(1):30-37. doi: 10.1200/JCO.20.00290. Epub 2020 Aug 21.
- Individual participant dataSharing planned: No
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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.
Ying Wang, Ph.D, M.D. principal investigator
Chongqing University Cancer Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Camrelizumab and Stereotactic body radiotherapy in people with Nasopharyngeal Carcinoma, run by Chongqing University Cancer Hospital at 3 sites 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 21 inclusion and 13 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 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Jiangdong Sui, Ph.D, M.D. (13594190011, jiangdong.sui@cqu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best overall response (BOR) (time frame: Time Frame: 96 weeks). 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 NCT04830267, which also lists 10 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 28 Mar 2024.