Advanced MelanomaPhase 2NCT03818893
Combination Therapy With GEN0101 and Pembrolizmub in Advanced Melanoma Patients PIb/PII
A Phase 2 study testing Combination of GEN0101 and Pembrolizmub in people with Advanced Melanoma, run by Osaka University at 7 sites in Japan.
Trial summary
This is a multi-center, open-labeled, non-randomized, single arm investigator-initiated trial to evaluate the safety and efficacy of GEN0101 and Pembrolizmub combination in patients with advanced melanoma. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Advanced Melanoma
- What is being tested?
- Combination of GEN0101 and Pembrolizmub
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 7 sitesJapan
- Study dates
- Mar 2019to 30 Jun 2022
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient will be eligible for this trial if all the following apply:
- Patient has given written informed consent by themselves
- Patient aged 20 to 85 years at the time of informed consent
- Patient has histologically- or cytologically-confirmed melanoma
- Patient with a diagnosis of incurable and unresectable, Stage IIIC, IIID or Stage IV advanced melanoma, showing confirmed SD or unconfirmed PD over 12-week treatment with an anti-PD-1 antibody such as nivolumab or Pembrolizumab. To be assigned a status of SD, changes in tumor measurements must be confirmed by consecutive repeat evaluations that should be performed in 4 to 6 weeks after the criteria for response are first met over 12-week of an anti-PD-1 antibody treatment.
- Patient has a measurable tumor
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- Patient has life expectancy of at least 12 weeks after the first dose of investigational product
- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening
- Patient has met the following criteria of clinical laboratory tests at screening (1)White blood cell (WBC) count over 3,000/μL and neutrophil count over 1,500/μL (2)Platelet count over over 75,000/μL (3)Hemoglobin over 8.0 g/dL (4)AST and ALT ≤ 2.5 × upper limit of normal (ULN) (5)Total bilirubin ≤ 2 × ULN (6)Serum creatinine ≤ 2 × ULN
- LDH is not higher than the 2-fold of the upper limit of the institutional reference.
- A female patient of childbearing potential (a premenopausal woman, a woman with medically or drug-induced amenorrhea, and a woman with no history of sterilization), who has agreed to use appropriate contraception, e.g., the barrier method and a total abstinence, during the trial treatment until 3 months passed after completion of the trial treatment. A male patient who has agreed to use appropriate contraception, e.g., the barrier method and a total abstinence, during the above period.
Who cannot join
- Patient will be excluded from participation if any of the following apply:
- Patient has brain metastases. Patients with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging* (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
- Patient has showed positive reaction in a prick testing for GEN0101
- A patient who has the mutant BRAF gene in a tumor biopsy.
- A patient who has current pneumonitis.
- Patient concurrently has an active infection requiring systemic therapy.
Show all 20Show fewer
- Patient has received other systemic anticancer therapy than an anti-PD-1 antibody therapy such as nivolumab, Pembrolizumab, or local IFN-beta therapy within 3 weeks before the time of informed consent (or within 6 weeks before the time of the informed consent for a patient who received nitrosourea or mitomycin C)
- Patient has received another unapproved drug other than anti-PD-L1 antibody within 4 weeks before the time of informed consent
- Patient has intraocular (uveal) melanoma
- Patient has or had another malignant tumor than melanoma. However, this criterion does not apply to a patient who has experienced neither recurrence nor metastasis for at least 5 years at the time of informed consent.
- Patient has received systemic corticosteroid or systemic immunosuppressant within 1 week before the first dose of investigational product. However, this criterion does not apply to a patient who has been on long-term (>6-month) treatment at a low dose (equivalent to oral prednisolone under 10 mg/day) or who received prophylactic immunosuppressant against contrast media allergy.
- Patient has received a live vaccine within 30 days before registration
- Patient has enrolled in another clinical trial and received an investigational product within 4 months before the first dose of investigational product, or patient has intended to be enrolled in another clinical trial in parallel with this clinical trial
- A patient who has an active TB infection.
- Female patient is pregnant (including one with positive results from a pregnancy test at screening), lactating, or intending to become pregnant during participation in this trial and before 3 months have passed after completion of this trial. However, this criterion does not apply to a patient who will stop lactating (from the date of informed consent until 30 days passed after the last treatment). Of note, female patients should undergo a beta-HCG test to demonstrate pregnancy status. Male patient who does not agree to use appropriate contraception such as the barrier method and a total abstinence during this trial until 3 months passed after the completion of this trial. (Detailed method is described in 5.7 Contraception)
- Patient has psychiatric disease considered to be a potential concern from the viewpoints of follow-up and protocol adherence
- Patient had given autografting or allografting of organ or tissue (receiving an immunosuppressant)
- Patient has over 10%-shorter prothrombin time (PT) compared to lower limit of normal (LLN) or over 1.5-fold longer activated partial thromboplastin time (APTT) compared to ULN at screening
- Patient has showed positive reaction to any of HBs antigen, HCV antibody, HIV-1 antibody, or HIV-2 antibody at screening. However, even if it is positive for HCV antibody, it should not be excluded when HCV RNA test is negative.
- Patient is considered ineligible for this trial by the investigator or the sub-investigators
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Japan7 sites, 7 recruiting
- Not yet recruiting
Tokyo Medical and Dental University
Bunkyo-ku, Tokyo, 113-8519
Tsuyoshi Namiki, Associ.Prof., 03-3813-6111
- Recruiting
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045
Naoya Yamazaki, Director, 03-3542-2511
- Recruiting
Kumamoto University Hospital
Kuramoto, Kumamoto, 860-8556
Satoshi Fukushima, Associ.Prof., 096-373-5233
- Not yet recruiting
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8550
Kenji Yokota, Lecture, 052-741-2111
- Not yet recruiting
Shizuoka Cancer Center
Nakatogari, Shizuoka, 411-8777
Yoshio Kiyohara, Director, 055-989-5222
- Not yet recruiting
Osaka International Cancer Institute
Osaka, 541-8567
Taiki Isei, Director, 06-6945-1181
- Not yet recruiting
Sapporo Medical University Hospital
Sapporo, Hokkaido, 060-8543
Hisashi Uhara, Professor, 011-611-2111
About this study
Official title: Phase Ib/II Investigator Initiated Safety and Efficacy Clinical Trial of Combination Therapy of Intracutaneous GEN0101 With Intravenous Pembrolizmub in Patients Who Have Advanced Melanoma
This is a multi-center, open-labeled, non-randomized, single arm investigator-initiated trial to evaluate the safety and efficacy of GEN0101 and Pembrolizmub combination in patients with advanced melanoma.
Read the detailed description
- Primary Objective \& Hypothesis
- Objective: Efficacy of the combination therapy The combination therapy with intracutaneous injections of GEN0101 + intravenous infusions of Pembrolizumab is given to patients with confirmed SD or unconfirmed PD after anti-PD-1 antibody therapy. When the last subject completes Week 13 (Day 85th), the RECIST v1.1-based antitumor effect is assessed for all the subjects up to Week 17 (Day 113th) and then the ORR is calculated in both treatment groups, which are tested to examine the significant difference to historical data of KEYNOTE-002.
- Hypothesis: The antitumor effect and the induction of antitumor immunity of the combination therapy would be enhanced.
- Secondary Objectives \& Hypothesises
- Objectives: Efficacy and safety of the combination therapy The combination therapy with intracutaneous injections of GEN0101 + intravenous infusions of Pembrolizumab is given to patients with confirmed SD or unconfirmed PD after anti-PD-1 antibody therapy. When the last subject completed Week 17 (Day 113th), antitumor effect in Week 13 (Day 85th, unconfirmed) and Week 17 (Day 113th, confirmed) is assessed based on RECIST v1.1, irRC, and irRECIST for all subjects and then the ORR is calculated. Likewise, changes in individual tumor sizes in Week 13 (Day 85th, unconfirmed) and Week 17 (Day 113th, confirmed) are measured, and then percent changes in tumor sizes (percent tumor shrinkage or growth) are calculated. In each subject, the induction of antitumor immunity in Week 13 (Day 85th) is investigated with the index of activated NK cells in peripheral blood. When the last subject completed Week 53 (Day 365th), antitumor effect is assessed for all the subjects based on OS and RECIST v1.1, irRC, and irRECIST-based ORR, BOR and PFS, which are tested to examine significant difference to historical data of KEYNOTE-002. When the last subject completed Week 105 (Day 729th), antitumor effect is assessed for all the subjects based on OS and RECIST v1.1, irRC, and irRECIST-based ORR, BOR and PFS, which are tested to examine significant difference to historical data of KEYNOTE-002. On the basis of these results, the antitumor effect and the induction of antitumor immunity of the combination therapy is investigated. These are secondary objectives in the trial. As another secondary objective, AEs are investigated in all the subjects for safety evaluation of the combination therapy until the last subject completed Week 105 (Day 729th).
- Hypothesis: The antitumor effect and the induction of antitumor immunity of the combination therapy would be enhanced and the safety would be acceptable.
- Exploratory Objective Objective: Storage and use of samples for future exploratory evaluation
- Conditions
- Advanced Melanoma
- Being tested
- Combination of GEN0101 and Pembrolizmub
- Keywords
- Cancer immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of GEN0101 and PembrolizmubDrug
New Combination immunotherapy GEN0101 and Pembrolizmub
| Study group | Role | What they receive |
|---|---|---|
| New Combination Immunotherapy | Experimental | Patients will receive Pembrolizumab once every 3 weeks and a maximum of 35 doses over 105 weeks .
The patients should be inpatient during treatment with GEN0101 in each treatment cycle and may be outpatient during off-treatment period with GEN0101, observation period, follow-up period with Pembrolizumab.
GEN0101 in a vial will be reconstituted with 1 mL of sterile distilled water and then will be injected intracutaneously (including skin tumor site). Nonetheless, it will not be deemed as deviation if an injection has been given subcutaneously unintentionally, e.g., leakage around the peri-injection sites.
A dose will be 60,000 mNAU in total, and 1 mL per injection site should be administered to 6 injection sites in total. For a patient, the total dose in a treatment cycle will be 360,000 mNAU (360 NAU), and the total dose over 2 treatment cycles will be 720,000 mNAU (720 NAU). Receives: Drug: Combination of GEN0101 and Pembrolizmub |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR), central review
As overall tumor response in all the tumors in each subject, the ORR is calculated based on the assessment results in Week 9 (Day 57th), Week 13 (Day 85th) and Week 17 (Day 113th) as confirmatory assessment.
Measured: until Week17 (Day113th)
Secondary outcomes (6)
Overall response rate (ORR) and Best overall response (BOR), investigator assessment and central review
In all the tumors in each subject, the RECIST v1.1-based, the irRC-based and the irRECIST-based overall tumor response is assessed by the site investigator until Week 105 (Day 729th). Then, based on the assessment results, the ORR and BOR are calculated.
Measured: until Week 105 (Day 729th)
Percent change in individual tumor sizes
Until Week 105 (Day 729th) in each subject, the size of each tumor is calculated by the longest diameter the perpendicular diameter of each tumor, and then percent changes in individual tumor sizes (percent shrinkage or growth) and the local Response Rates are calculated
Measured: Until Week 105 (Day 729th)
Progression free survival (PFS)
When the last subject completed Week 22 (Day 148th) (and Week 26 as confirmatory assessment of PD) and Week 53 (Day 365th) and Week 105 (Day 729th) of GEN0101, the RECIST v1.1-based PFS is assessed for all the subjects, where the assessment results in Week 8 should not be used and the central assessment results since Week 13 (Day 85th) only are used for all the subjects.
Measured: Until Week 105 (Day 729th)
Overall survival (OS)
When the last subject completes Week 22 (Day 148th) and Week 53 (Day 365th) and Week 105 (Day 729th) of GEN0101, OS is calculated for all the subjects.
Measured: Until Week 105 (Day 729th)
Induction of antitumor immunity
In Week 9 (Day 57th) and Week 13 (Day 85th) of GEN0101 in each subject, the induction of antitumor immunity after the combination therapy is investigated with the index of peripheral blood activated NK cells.
Measured: Week 13 (Day 85th)
Adverse Events
AEs occurring in each subject up to Week 105 (Day 729th) of GEN0101 are evaluated with CTCAE v4.03
Measured: up to Week 105 (Day 729th)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study startMar 2019 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced MelanomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Osaka University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, ISHIHARA SANGYO KAISHA,LTD. Japan
- Responsible party
- Sponsor
- Investigators
- Atsushi Tanemura, Lecture, Principal investigator, Osaka University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818893
- Sponsor's protocol ID
- GEN0101-JM005
- Status last verified
- Jan 2019
- First submitted
- 24 Jan 2019
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib/II Investigator Initiated Safety and Efficacy Clinical Trial of Combination Therapy of Intracutaneous GEN0101 With Intravenous Pembrolizmub in Patients Who Have Advanced Melanoma
- ClinicalTrials.gov ID
- NCT03818893
- Acronym / sponsor ID
- GEN0101-JM005
- Conditions
- Advanced Melanoma
- Keywords
- Cancer immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Osaka UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, ISHIHARA SANGYO KAISHA,LTD. Japan
- Study start
- Mar 2019 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 28 Jan 2019 (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 is a multi-center, open-labeled, non-randomized, single arm investigator-initiated trial to evaluate the safety and efficacy of GEN0101 and Pembrolizmub combination in patients with advanced melanoma.
Detailed description
- Primary Objective \& Hypothesis
- Objective: Efficacy of the combination therapy The combination therapy with intracutaneous injections of GEN0101 + intravenous infusions of Pembrolizumab is given to patients with confirmed SD or unconfirmed PD after anti-PD-1 antibody therapy. When the last subject completes Week 13 (Day 85th), the RECIST v1.1-based antitumor effect is assessed for all the subjects up to Week 17 (Day 113th) and then the ORR is calculated in both treatment groups, which are tested to examine the significant difference to historical data of KEYNOTE-002.
- Hypothesis: The antitumor effect and the induction of antitumor immunity of the combination therapy would be enhanced.
- Secondary Objectives \& Hypothesises
- Objectives: Efficacy and safety of the combination therapy The combination therapy with intracutaneous injections of GEN0101 + intravenous infusions of Pembrolizumab is given to patients with confirmed SD or unconfirmed PD after anti-PD-1 antibody therapy. When the last subject completed Week 17 (Day 113th), antitumor effect in Week 13 (Day 85th, unconfirmed) and Week 17 (Day 113th, confirmed) is assessed based on RECIST v1.1, irRC, and irRECIST for all subjects and then the ORR is calculated. Likewise, changes in individual tumor sizes in Week 13 (Day 85th, unconfirmed) and Week 17 (Day 113th, confirmed) are measured, and then percent changes in tumor sizes (percent tumor shrinkage or growth) are calculated. In each subject, the induction of antitumor immunity in Week 13 (Day 85th) is investigated with the index of activated NK cells in peripheral blood. When the last subject completed Week 53 (Day 365th), antitumor effect is assessed for all the subjects based on OS and RECIST v1.1, irRC, and irRECIST-based ORR, BOR and PFS, which are tested to examine significant difference to historical data of KEYNOTE-002. When the last subject completed Week 105 (Day 729th), antitumor effect is assessed for all the subjects based on OS and RECIST v1.1, irRC, and irRECIST-based ORR, BOR and PFS, which are tested to examine significant difference to historical data of KEYNOTE-002. On the basis of these results, the antitumor effect and the induction of antitumor immunity of the combination therapy is investigated. These are secondary objectives in the trial. As another secondary objective, AEs are investigated in all the subjects for safety evaluation of the combination therapy until the last subject completed Week 105 (Day 729th).
- Hypothesis: The antitumor effect and the induction of antitumor immunity of the combination therapy would be enhanced and the safety would be acceptable.
- Exploratory Objective Objective: Storage and use of samples for future exploratory evaluation
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| New Combination Immunotherapy | Experimental | Drug: Combination of GEN0101 and PembrolizmubPatients will receive Pembrolizumab once every 3 weeks and a maximum of 35 doses over 105 weeks . The patients should be inpatient during treatment with GEN0101 in each treatment cycle and may be outpatient during off-treatment period with GEN0101, observation period, follow-up period with Pembrolizumab. GEN0101 in a vial will be reconstituted with 1 mL of sterile distilled water and then will be injected intracutaneously (including skin tumor site). Nonetheless, it will not be deemed as deviation if an injection has been given subcutaneously unintentionally, e.g., leakage around the peri-injection sites. A dose will be 60,000 mNAU in total, and 1 mL per injection site should be administered to 6 injection sites in total. For a patient, the total dose in a treatment cycle will be 360,000 mNAU (360 NAU), and the total dose over 2 treatment cycles will be 720,000 mNAU (720 NAU). |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient has given written informed consent by themselves
- Patient aged 20 to 85 years at the time of informed consent
- Patient has histologically- or cytologically-confirmed melanoma
- Patient with a diagnosis of incurable and unresectable, Stage IIIC, IIID or Stage IV advanced melanoma, showing confirmed SD or unconfirmed PD over 12-week treatment with an anti-PD-1 antibody such as nivolumab or Pembrolizumab. To be assigned a status of SD, changes in tumor measurements must be confirmed by consecutive repeat evaluations that should be performed in 4 to 6 weeks after the criteria for response are first met over 12-week of an anti-PD-1 antibody treatment.
- Patient has a measurable tumor
Key exclusion criteria (20 listed)
- Patient has brain metastases. Patients with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging* (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
- Patient has showed positive reaction in a prick testing for GEN0101
- A patient who has the mutant BRAF gene in a tumor biopsy.
- A patient who has current pneumonitis.
- Patient concurrently has an active infection requiring systemic therapy.
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 |
|---|---|---|
| Combination of GEN0101 and PembrolizmubNew Combination immunotherapy GEN0101 and Pembrolizmub | Drug | New Combination Immunotherapy |
Primary outcome
Overall response rate (ORR), central review
Time frame: until Week17 (Day113th)
As overall tumor response in all the tumors in each subject, the ORR is calculated based on the assessment results in Week 9 (Day 57th), Week 13 (Day 85th) and Week 17 (Day 113th) as confirmatory assessment.
6 secondary outcomes
Overall response rate (ORR) and Best overall response (BOR), investigator assessment and central review
Time frame: until Week 105 (Day 729th)
Percent change in individual tumor sizes
Time frame: Until Week 105 (Day 729th)
Progression free survival (PFS)
Time frame: Until Week 105 (Day 729th)
Overall survival (OS)
Time frame: Until Week 105 (Day 729th)
Induction of antitumor immunity
Time frame: Week 13 (Day 85th)
Adverse Events
Time frame: up to Week 105 (Day 729th)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- 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.
Atsushi Tanemura, Lecture principal investigator
Osaka University Hospital
7 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 Combination of GEN0101 and Pembrolizmub in people with Advanced Melanoma, run by Osaka University at 7 sites in Japan.
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 11 inclusion and 20 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 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Japan. 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 Atsushi Tanemura, Lecture (06-6879-3039, tanemura@derma.med.osaka-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR), central review (time frame: until Week17 (Day113th)). 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 30 Jan 2019.