Recurrent or Metastatic Nasopharyngeal CarcinomPhase 2HN17-11NCT06440187
Nivolumab Plus Gemcitabine in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma-HN17-11
A Phase 2 study testing Gemcitabine+ nivolumab in people with Recurrent or Metastatic Nasopharyngeal Carcinom, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
NPC is a highly chemo-sensitive cancer. Platinum-containing doublet chemotherapy is regarded as the standard treatment for patients with recurrent or metastatic NPC, even though it has never been directly compared with supportive care. Until now, no randomized trials have defined the optimum regimens. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Recurrent or Metastatic Nasopharyngeal Carcinom
- What is being tested?
- Gemcitabine+ nivolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Jun 2018to 30 Apr 2021
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Histologically confirmed nasopharyngeal carcinoma
- Recurred after local treatment or metastatic disease. Disease that is not amenable to surgery, radiation or combined modality therapy with curative intent
- Received at least one line of palliative chemotherapy
- Presence of at least one measurable target lesion for further evaluation according to RECIST 1.1 criteria. Progressive lesions after radiation therapy can also be a target lesion. However, patients who were refractory to initial CCRT with platinum therapy (recurred within 6 months) were excluded.
- 20 years or older
- ECOG performance status 0, 1
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- Adequate organ function ANC ≥ 1500/ μL Platelets ≥100,000/ μL Hemoglobin ≥ 9.0 g/dL Serum creatinine ≤1.5 x ULN Serum bilirubin ≤1.5 x ULN AST, ALT, ≤3.0 x ULN (regardless of liver metastasis)
- A patient with the willingness to comply with the study protocol during the study period and capable of complying with it
- A patient who signed the informed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages.
Who cannot join
- A patient with no measurable disease
- A patient with previous active or passive immunotherapy or immune check point blocking agents or gemcitabine.
- Active HBV (HBV DNA is positive) or HCV (HCV RNA is detected) or HIV infection. (inactive HBsAg carrier with prophylactic antiviral treatment can be enrolled)
- A pregnant or lactating patient
- A patient of childbearing potential without being tested for pregnancy at baseline or with being tested for positive. (A postmenopausal woman with the amenorrhea period of at least 12 months or longer is considered to have non-childbearing potential)
- A man or woman of childbearing potential who has no willingness to use a contraceptive measure during the study
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- A patient with history of another malignant disease within past 5 years, except curatively treated basal cell carcinoma of skin, early gastric cancer, and cervical carcinoma in situ.
- A patient with history of uncontrolled seizures, central nervous system disorder or psychiatric disorders that are considered clinically significant by the investigator that would prohibit the understanding of informed consent or that may be considered to interfere with the compliance of the administration of the study medications.
- A patient with clinically significant heart disease (e.g. congestive heart failure, symptomatic coronary artery diseases, cardiac arrhythmia, etc) or myocardial infarction within past 12 months.
- Ongoing cardiac arrhythmia of grade ≥2, atrial fibrillation of any grade, or QTc interval>450msec for males or >470msec for female.
- A patient with interstitial pneumonia or diffuse symptomatic fibrosis of the lungs
- A patient with organ transplantation requiring immunosuppressive therapy
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Internal Medicine, Seoul National University Hospital
Seoul, 110-744
About this study
Official title: Phase II Study of Nivolumab Plus Gemcitabine in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma-HN17-11
NPC is a highly chemo-sensitive cancer. Platinum-containing doublet chemotherapy is regarded as the standard treatment for patients with recurrent or metastatic NPC, even though it has never been directly compared with supportive care. Until now, no randomized trials have defined the optimum regimens. At present, cisplatin plus continuous intravenous infusion of fluorouracil is widely used in patients with recurrent or metastatic nasopharyngeal carcinoma, with a response rate of 40-65%.
Gemcitabine single is active and tolerable agent for recurred or metastatic NPC. Response rate (RR) was 34% and progression-free survival (PFS) was 5.0 months . Moreover, gemcitabine reduces the frequency of CD11b+GR1+ myeloid suppressor cells. Gemcitabine-induced apoptosis of established tumours may enhance the dendritic cell dependent cross-presentation of tumor antigens to T cells. Gemcitabine can function in synergy with CD40 stimulation of T cells. Hence, theoretically gemcitabine can have synergistic effect with PD-1/PD-L1 blocking agent.
Immunotherapy with immune checkpoint inhibitors has gradually emerged as a promising treatment modality for head and necks squamous cell carcinoma and NPC.
Read the detailed description
Based on these evidences which suggest a function for PD-1/PD-L1 in NPC and potential synergistic effect with gemcitabine, the use of nivolumab in recurred/metastatic NPC is reasonable and valuable. So we design this phase II study of nivolumab and gemcitabine in recurred/metastatic NPC which is common cancer in Asian.
- Being tested
- Gemcitabine+ nivolumab
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine+ nivolumabDrug
Also called Experimental group
Gemcitabine+ nivolumab q 2wks
| Study group | Role | What they receive |
|---|---|---|
| gemcitabine+ nivolumab | Experimental | Nivolumab administration on D1 and D15 every cycle, with 3mg/kg with gmecitabine co-administration on D1 and D15 every cycle, with 1250mg/m2 Receives: Drug: Gemcitabine+ nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
the percentage of patients who have not experienced disease progression or death from any cause from the start of treatment.
Measured: From the first date of treatment to the date occurring disease progression or death from any cause
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start8 Jun 2018
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent or Metastatic Nasopharyngeal CarcinomStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- gemcitabine + nivolumab
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bhumsuk Keam, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06440187
- Sponsor's protocol ID
- KCSG-HN-17-11
- Acronym
- HN17-11
- Status last verified
- May 2024
- First submitted
- 6 Jun 2018
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Nivolumab Plus Gemcitabine in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma-HN17-11
- ClinicalTrials.gov ID
- NCT06440187
- Acronym / sponsor ID
- HN17-11 / KCSG-HN-17-11
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 8 Jun 2018 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 3 Jun 2024 (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.
NPC is a highly chemo-sensitive cancer. Platinum-containing doublet chemotherapy is regarded as the standard treatment for patients with recurrent or metastatic NPC, even though it has never been directly compared with supportive care. Until now, no randomized trials have defined the optimum regimens. At present, cisplatin plus continuous intravenous infusion of fluorouracil is widely used in patients with recurrent or metastatic nasopharyngeal carcinoma, with a response rate of 40-65%.
Gemcitabine single is active and tolerable agent for recurred or metastatic NPC. Response rate (RR) was 34% and progression-free survival (PFS) was 5.0 months . Moreover, gemcitabine reduces the frequency of CD11b+GR1+ myeloid suppressor cells. Gemcitabine-induced apoptosis of established tumours may enhance the dendritic cell dependent cross-presentation of tumor antigens to T cells. Gemcitabine can function in synergy with CD40 stimulation of T cells. Hence, theoretically gemcitabine can have synergistic effect with PD-1/PD-L1 blocking agent.
Immunotherapy with immune checkpoint inhibitors has gradually emerged as a promising treatment modality for head and necks squamous cell carcinoma and NPC.
Detailed description
Based on these evidences which suggest a function for PD-1/PD-L1 in NPC and potential synergistic effect with gemcitabine, the use of nivolumab in recurred/metastatic NPC is reasonable and valuable. So we design this phase II study of nivolumab and gemcitabine in recurred/metastatic NPC which is common cancer in Asian.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- gemcitabine + nivolumab
| Arm | Type | Receives |
|---|---|---|
| gemcitabine+ nivolumab | Experimental | Drug: Gemcitabine+ nivolumabNivolumab administration on D1 and D15 every cycle, with 3mg/kg with gmecitabine co-administration on D1 and D15 every cycle, with 1250mg/m2 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed nasopharyngeal carcinoma
- Recurred after local treatment or metastatic disease. Disease that is not amenable to surgery, radiation or combined modality therapy with curative intent
- Received at least one line of palliative chemotherapy
- Presence of at least one measurable target lesion for further evaluation according to RECIST 1.1 criteria. Progressive lesions after radiation therapy can also be a target lesion. However, patients who were refractory to initial CCRT with platinum therapy (recurred within 6 months) were excluded.
- 20 years or older
Key exclusion criteria (12 listed)
- A patient with no measurable disease
- A patient with previous active or passive immunotherapy or immune check point blocking agents or gemcitabine.
- Active HBV (HBV DNA is positive) or HCV (HCV RNA is detected) or HIV infection. (inactive HBsAg carrier with prophylactic antiviral treatment can be enrolled)
- A pregnant or lactating patient
- A patient of childbearing potential without being tested for pregnancy at baseline or with being tested for positive. (A postmenopausal woman with the amenorrhea period of at least 12 months or longer is considered to have non-childbearing potential)
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 |
|---|---|---|
| Gemcitabine+ nivolumabAlso: Experimental groupGemcitabine+ nivolumab q 2wks | Drug | gemcitabine+ nivolumab |
Primary outcome
Progression free survival
Time frame: From the first date of treatment to the date occurring disease progression or death from any cause
the percentage of patients who have not experienced disease progression or death from any cause from the start of treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine+ nivolumab in people with Recurrent or Metastatic Nasopharyngeal Carcinom, run by Seoul National University Hospital at 1 site in South Korea.
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 9 inclusion and 12 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: finished, as of the sponsor's last update on 3 Jun 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: From the first date of treatment to the date occurring disease progression or death from any cause). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2024.