MelanomaPhase 2NCT05051865
To Explore the Efficacy and Safety of Camrelizumab Combined With SHR1020 in the Treatment of Advanced Melanoma
A Phase 2 study testing camrelizumab and SHR1020 in people with Melanoma, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
This study is being conducted to explore the efficacy and safety of camrelizumab combined with SHR1020 in the treatment of advanced melanoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Melanoma
- What is being tested?
- camrelizumab and SHR1020
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2021to 30 Aug 2024
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has unresectable Stage III or Stage IV melanoma per American Joint Committee on Cancer (AJCC) staging system version 8. At least one measurable lesion conforming to RECIST 1.1 criteria.
- The toxicity of prior treatment has recovered to ≤1 grade according to CTCAE 5.0 (excepted alopecia).
- ECOG score 0-1.
- The expected survival time is ≥ 12 weeks.
- Had normal swallowing function, without dysfunction of gastrointestinal absorption.
- Adequate organ and bone marrow function.
- Female patients of childbearing age must undergo a serum pregnancy test within 7 days before the commencement of the study and the results are negative, and are willing to use a medically approved high potency contraceptive method during the study period and within 12 months after the last administration of the study drug; For male patients whose partner is a female of childbearing age, they should be surgically sterilized or agree to use an effective method of contraception during the study period and for 12 months after administration of the last study.
- Willing to consent and signed the informed consent, and able comply with the planned visit, research treatment, laboratory examination and other test procedures.
Who cannot join
- Other malignant tumors occurred in the past 5 years, except for cured skin basal cell carcinoma, squamous cell carcinoma of skin, early stage prostate cancer and cervical carcinoma in situ.
- Has uveal melanoma.
- The patient has previously received anti-angiogenic drugs.
- The first study drug treatment was less than 4 weeks from the last chemotherapy or 5 half-lives from the last targeted therapy; less than 4 weeks from major surgery; less than7 days from immunosuppressive drug; less than 3 weeks from immunomodulatory; less than 4 weeks from live attenuated vaccine.
- Systemic antibiotic use for 7 days within 4 weeks prior to initial administration, or unexplained fever during screening/prior to initial administration.
- Received hematopoietic stimulating factors (eg: G-CSF, EPO) within 1 week prior to initial administration.
Show all 14Show fewer
- Patients with central nervous system disease or brain metastases; patients who have received treatment, such as imaging confirmed stable has been maintained for at least 4 weeks, and have stopped systemic hormone therapy for more than 2 weeks, no clinical symptoms can be included.
- With active autoimmune disease or a history of autoimmune disease.
- With history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- With immunodeficiency, eg HIV, HBV, HCV.
- Known to be allergic to the active ingredients or excipients in this study.
- Have a clear history of serious and uncontrolled other disease or mental disorders.
- Has a bleeding tendency or abnormal clotting function (INR>2.0, PT>16s).
- Other situations that the researcher considers inappropriate to participate in the research.
Trial locations and contacts
1 site in 1 country.
Jun Guo, MD contact
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Jun Guo, MD, +861088196348, guoj307@126.com
About this study
Official title: A Prospective, Single-center Clinical Study to Explore the Efficacy and Safety of Camrelizumab Combined With SHR1020 in the Treatment of Advanced Melanoma
This study is being conducted to explore the efficacy and safety of camrelizumab combined with SHR1020 in the treatment of advanced melanoma.
Read the detailed description
This trial is a prospective, single-center, single-arm clinical research. Based on current experience, single agent immunotherapy has limited efficacy in advanced melanoma. SHR1020 is a multi-target tyrosine kinase inhibitor. This study is aiming to evaluate the efficacy and safety of camrelizumab combined with SHR1020 in patients with advanced melanoma. The safety and efficacy of this study will be assessed through ORR, DCR, PFS, OS and adverse effects as graded by CTCAE 5.0.
- Conditions
- Melanoma
- Being tested
- camrelizumab, SHR1020
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
camrelizumabDrug
Also called SHR1210
camrelizumab combined with SHR1020 for advanced melanoma
SHR1020Drug
camrelizumab combined with SHR1020 for advanced melanoma
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab Combined With SHR1020 | Experimental | Camrelizumab combined with SHR1020 for advanced melanoma. Receives: Drug: camrelizumab; Drug: SHR1020 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR (Objective Response Rate)
Containing the incidence of complete response (CR) and partial response (PR). Evaluated according to RECIST 1.1 criteria, patients received their first tumor imaging evaluation at 6 weeks after the treatment start, followed by imaging evaluation every 2 cycles.
Measured: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Secondary outcomes (5)
PFS (Progression-Free-Survival)
From date of treatment start until the date of progression or the date of death due to any cause. Evaluated according to RECIST 1.1 criteria, patients received their first tumor imaging evaluation at 6 weeks after the treatment start, followed by imaging evaluation every 2 cycles.
Measured: From date of treatment start until the date of progression or the date of death due to any caus, assessed up to 12 months
DCR (Disease Control Rate)
Containing the incidence of complete response (CR), partial response (PR) and stable disease (SD).Evaluated according to RECIST 1.1 criteria, patients received their first tumor imaging evaluation at 6 weeks after the treatment start, followed by imaging evaluation every 2 cycles.
Measured: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
OS (overall survival)
From date of treatment start to any cause death or last follow-up.
Measured: From date of treatment start until the date of death from any cause or censored at the last day that the patient is documented to be alive, whichever came first, assessed up to 24 months
6mPFS
6-month- Progression-Free-Survival rate. Evaluated according to RECIST 1.1 criteria, patients received their first tumor imaging evaluation at 6 weeks after the treatment start, followed by imaging evaluation every 2 cycles.
Measured: Up to 6 months
Adverse events (per CTCAE v5.0 criteria)
To evaluate the adverse events of patients with advanced melanoma after treated with camrelizumab plus SHR1020.
Measured: Up to 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start9 Oct 2021
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Guo, Peking University Cancer Hospital & Institute
- Investigators
- Jun Guo, MD, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05051865
- Sponsor's protocol ID
- MM-IIT-SHR1210-FMTN
- Status last verified
- Nov 2022
- First submitted
- 15 Sep 2021
- Last updated
- 17 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center Clinical Study to Explore the Efficacy and Safety of Camrelizumab Combined With SHR1020 in the Treatment of Advanced Melanoma
- ClinicalTrials.gov ID
- NCT05051865
- Acronym / sponsor ID
- MM-IIT-SHR1210-FMTN
- Conditions
- Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 9 Oct 2021 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 21 Sep 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.
This study is being conducted to explore the efficacy and safety of camrelizumab combined with SHR1020 in the treatment of advanced melanoma.
Detailed description
This trial is a prospective, single-center, single-arm clinical research. Based on current experience, single agent immunotherapy has limited efficacy in advanced melanoma. SHR1020 is a multi-target tyrosine kinase inhibitor. This study is aiming to evaluate the efficacy and safety of camrelizumab combined with SHR1020 in patients with advanced melanoma. The safety and efficacy of this study will be assessed through ORR, DCR, PFS, OS and adverse effects as graded by CTCAE 5.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab Combined With SHR1020 | Experimental | Drug: camrelizumab, Drug: SHR1020Camrelizumab combined with SHR1020 for advanced melanoma. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Has unresectable Stage III or Stage IV melanoma per American Joint Committee on Cancer (AJCC) staging system version 8. At least one measurable lesion conforming to RECIST 1.1 criteria.
- The toxicity of prior treatment has recovered to ≤1 grade according to CTCAE 5.0 (excepted alopecia).
- ECOG score 0-1.
- The expected survival time is ≥ 12 weeks.
- Had normal swallowing function, without dysfunction of gastrointestinal absorption.
Key exclusion criteria (14 listed)
- Other malignant tumors occurred in the past 5 years, except for cured skin basal cell carcinoma, squamous cell carcinoma of skin, early stage prostate cancer and cervical carcinoma in situ.
- Has uveal melanoma.
- The patient has previously received anti-angiogenic drugs.
- The first study drug treatment was less than 4 weeks from the last chemotherapy or 5 half-lives from the last targeted therapy; less than 4 weeks from major surgery; less than7 days from immunosuppressive drug; less than 3 weeks from immunomodulatory; less than 4 weeks from live attenuated vaccine.
- Systemic antibiotic use for 7 days within 4 weeks prior to initial administration, or unexplained fever during screening/prior to initial administration.
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: SHR1210camrelizumab combined with SHR1020 for advanced melanoma | Drug | Camrelizumab Combined With SHR1020 |
| SHR1020camrelizumab combined with SHR1020 for advanced melanoma | Drug | Camrelizumab Combined With SHR1020 |
Primary outcome
ORR (Objective Response Rate)
Time frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Containing the incidence of complete response (CR) and partial response (PR). Evaluated according to RECIST 1.1 criteria, patients received their first tumor imaging evaluation at 6 weeks after the treatment start, followed by imaging evaluation every 2 cycles.
5 secondary outcomes
PFS (Progression-Free-Survival)
Time frame: From date of treatment start until the date of progression or the date of death due to any caus, assessed up to 12 months
DCR (Disease Control Rate)
Time frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
OS (overall survival)
Time frame: From date of treatment start until the date of death from any cause or censored at the last day that the patient is documented to be alive, whichever came first, assessed up to 24 months
6mPFS
Time frame: Up to 6 months
Adverse events (per CTCAE v5.0 criteria)
Time frame: Up to 12months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
Related trials for Melanoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
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.
Jun Guo, MD contact
Jun Guo, MD principal investigator
Peking University Cancer Hospital & Institute
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 camrelizumab and SHR1020 in people with Melanoma, run by Peking University Cancer Hospital & Institute 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 17 Nov 2022. 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 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 Lili Mao, MD (13261859885, yunzhongmanbu7848@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (Objective Response Rate) (time frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months). 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 17 Nov 2022.