Stage IIIB Merkel Cell CarcinomaPhase 2NCT02465957
QUILT-3.009: Patients With Stage III (IIIB) or Stage (IV) Merkel Cell Carcinoma (MCC)
A Phase 2 study testing aNK (NK-92) and aNK (NK-92) + N-803 in people with Stage IIIB Merkel Cell Carcinoma and Stage IV Merkel Cell Carcinoma, run by ImmunityBio, Inc. at 3 sites in United States.
Trial summary
Phase II study to determine the effects of aNK infusions in combination with ALT-803 in patients with stage III (IIIB) or stage (IV) merkel cell carcinoma (MCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IIIB Merkel Cell Carcinoma, Stage IV Merkel Cell Carcinoma
- What is being tested?
- aNK (NK-92) and aNK (NK-92) + N-803
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 3 sitesUnited States
- Study dates
- 24 Sep 2015to 19 Mar 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or female patients 18 years of age or older.
- Patients must have histologically confirmed MCC that is Stage III (IIIB) or Stage IV, as defined by the 2010 AJCC staging criteria for MCC. MCC of unknown primary is allowed.
- Prior systemic cytotoxic chemotherapies and/or novel immunotherapy treatments for MCC are allowed. A wash-out period of 2 weeks prior to aNK treatment will be required.
- ECOG performance status of 0-2.
- Voluntary written informed consent must be given before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
- Mandatory diagnostic biopsy and whole blood sample are required. The tumor biopsy tissue will be analyzed for the presence of immune cells and will also undergo genomic, transcriptomic, and proteomic profiling.
Who cannot join
- Major surgery within 30 days before study entry.
- Any of the following clinical laboratory values at the time of enrollment:
- Absolute neutrophil count (ANC) < 1,000 cells/mm^3.
- Platelets < 50,000 x 10^9/L.
- Liver function abnormalities as indicated by ongoing hepatic enzyme elevation (e.g. AST, ALT, GGT) > 2 x the ULN. Elevation related to direct tumor infiltration is allowed.
- Renal insufficiency as indicated by a creatinine level > 2 x the ULN.
Show all 18Show fewer
- Myocardial infarction within 6 months prior to enrollment or New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled arrhythmias, or electrocardiographic evidence of acute ischemia or significant conduction system abnormalities in the opinion of the Investigator. Prior to study entry any known abnormality on an electrocardiogram (ECG) must be determined and documented by the Investigator to be not clinically significant to the patient participation in this study.
- Any condition, including laboratory abnormalities, that in the opinion of the Investigator places the patient at unacceptable risk if he/she were to participate in the study. This includes, but is not limited to, serious medical conditions or psychiatric illness likely to interfere with participation in this clinical study.
- Female patients who are pregnant or breastfeeding. Female patients of childbearing potential must have a negative pregnancy test and agree to use adequate contraception for the duration of the trial.
- Patients with other malignancies or brain metastasis are not eligible; however, given the frequent coexistence of MCC with other malignancies, the following exceptions are allowed:
- Patients who have been continuously disease-free for any solid tumor malignancy >3 years prior to the time of enrollment.
- Patients with basal cell carcinoma or squamous cell carcinoma.
- Patients with prior history of in situ cancer (e.g., breast, melanoma, squamous cells carcinoma of the skin, cervical).
- Patients with prior history of prostate cancer that is not under active systemic treatment (except hormonal therapy), but with undetectable PSA (<0.2 ng/mL).
- Patients with chronic non-T-cell-based lymphocytic leukemia are eligible if they have isolated lymphocytosis (Rai stage O) on the condition that they do not require systemic treatment for their disease ["B" symptoms, Richter's transformation, lymphocyte doubling time (<6 months) and they do not have lymphadenopathy of hepatosplenomegaly].
- Patients with non-T-cell-based lymphoma of any type or hairy cell leukemia are eligible on the condition that they do not receive active systemic treatment for their hematologic disease and are in complete remission as evidenced by PET/CT scans and bone marrow biopsies for at least 3 months.
- Patients on immunosuppressants, systemic corticosteroids, or any other investigational product.
- Patients unwilling to consent to analysis of their tumor tissue.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Robert H. Lurie Comprehensive Cancer Center
Chicago, Illinois, 60611
UPMC Cancer Center
Pittsburgh, Pennsylvania, 15232
Seattle Cancer Care Alliance
Seattle, Washington, 98109
About this study
Official title: Phase 2 Study of aNK (Activated NK-92 Natural Killer Cells) Infusions in Combination With ALT-803 (IL-15) in Patients With Stage III (IIIB) or Stage IV Merkel Cell Carcinoma (MCC)
Phase II study to determine the effects of aNK infusions in combination with ALT-803 in patients with stage III (IIIB) or stage (IV) merkel cell carcinoma (MCC).
Read the detailed description
This is a multi-center, non-randomized, open-label, phase 2 trial to determine the effects of aNK in combination with ALT-803 in patients with stage III (IIIB) or stage IV MCC. The study will use an adaptive Simon optimal two-stage design, which detects efficacy signals, allows for early assessment, and avoids enrolling larger numbers of patients in case of inefficacy.
In the original protocol, an initial cohort of up to 12 patients with stage III (IIIB) or stage IV MCC were to be enrolled and treated with aNK monotherapy (first stage). If the treatment in the first stage improved the 4-month progression free survival (PFS) rate from 4% to 20% (e.g. at least 1 patient out of 12 patients has PFS ≥ 16 weeks [4 months]), then the study would proceed to the second stage, in which 12 more patients were planned to be enrolled and treated. As of July 2016, the trial has met the required efficacy signal defined for the first stage and will continue to enroll a planned total of 24 patients who will receive the combination of aNK and ALT-803. Any patients who are already receiving aNK cells as monotherapy will receive aNK cells in combination with ALT-803 in subsequent cycles.
aNK will be given via IV infusion at a dose of 2 x 10^9 cells/m^2 on two consecutive days (= 1 cycle) every 2 weeks. In addition, ALT-803 will be administered SC at 10 μg/kg on the first day of every aNK infusion (before the aNK infusion) every 2 weeks.
- Being tested
- aNK (NK-92), aNK (NK-92) + N-803
- Keywords
- Merkel Cell Carcinoma, Neukoplast, NK-92, Natural Killer Cell, MCC, aNK
- Medical subject headings
- Carcinoma, Merkel Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aNK (NK-92)Biological
Also called NK-92, Neukoplast
A natural killer cell line recovered from a patient with large granular lymphoma
aNK (NK-92) + N-803Biological
aNK - A natural killer cell line recovered from a patient with large granular lymphoma and N-803 - Recombinant human super agonist interleukin-15 (IL-15) complex
| Study group | Role | What they receive |
|---|---|---|
| aNK (NK-92) | Experimental | aNK (activated NK-92, formerly Neukoplast) Receives: Biological: aNK (NK-92) |
| aNK (NK-92) + N-803 | Experimental | aNK (activated NK-92, formerly Neukoplast) and N-803 Receives: Biological: aNK (NK-92) + N-803 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Progression Free Survival Rate at 4 Months
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study start24 Sep 2015
- Primary completion19 Mar 2018
- Study completion19 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stage IIIB Merkel Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by ImmunityBio, Inc.The 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImmunityBio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02465957
- Sponsor's protocol ID
- QUILT-3.009
- Other IDs
- MCC-001
- Status last verified
- Aug 2020
- First submitted
- 3 Jun 2015
- Last updated
- 2 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of aNK (Activated NK-92 Natural Killer Cells) Infusions in Combination With ALT-803 (IL-15) in Patients With Stage III (IIIB) or Stage IV Merkel Cell Carcinoma (MCC)
- ClinicalTrials.gov ID
- NCT02465957
- Acronym / sponsor ID
- QUILT-3.009
- Keywords
- Merkel Cell Carcinoma, Neukoplast, NK-92, Natural Killer Cell, MCC, aNK
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 7 participants (actual)
- Lead sponsor
- ImmunityBio, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Sep 2015 (actual)
- Primary completion
- 19 Mar 2018 (actual)
- Study completion
- 19 Mar 2018 (actual)
- First posted
- 9 Jun 2015 (estimated)
- Results
- Posted 2 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase II study to determine the effects of aNK infusions in combination with ALT-803 in patients with stage III (IIIB) or stage (IV) merkel cell carcinoma (MCC).
Detailed description
This is a multi-center, non-randomized, open-label, phase 2 trial to determine the effects of aNK in combination with ALT-803 in patients with stage III (IIIB) or stage IV MCC. The study will use an adaptive Simon optimal two-stage design, which detects efficacy signals, allows for early assessment, and avoids enrolling larger numbers of patients in case of inefficacy.
In the original protocol, an initial cohort of up to 12 patients with stage III (IIIB) or stage IV MCC were to be enrolled and treated with aNK monotherapy (first stage). If the treatment in the first stage improved the 4-month progression free survival (PFS) rate from 4% to 20% (e.g. at least 1 patient out of 12 patients has PFS ≥ 16 weeks [4 months]), then the study would proceed to the second stage, in which 12 more patients were planned to be enrolled and treated. As of July 2016, the trial has met the required efficacy signal defined for the first stage and will continue to enroll a planned total of 24 patients who will receive the combination of aNK and ALT-803. Any patients who are already receiving aNK cells as monotherapy will receive aNK cells in combination with ALT-803 in subsequent cycles.
aNK will be given via IV infusion at a dose of 2 x 10^9 cells/m^2 on two consecutive days (= 1 cycle) every 2 weeks. In addition, ALT-803 will be administered SC at 10 μg/kg on the first day of every aNK infusion (before the aNK infusion) every 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aNK (NK-92) | Experimental | Biological: aNK (NK-92)aNK (activated NK-92, formerly Neukoplast) |
| aNK (NK-92) + N-803 | Experimental | Biological: aNK (NK-92) + N-803aNK (activated NK-92, formerly Neukoplast) and N-803 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients 18 years of age or older.
- Patients must have histologically confirmed MCC that is Stage III (IIIB) or Stage IV, as defined by the 2010 AJCC staging criteria for MCC. MCC of unknown primary is allowed.
- Prior systemic cytotoxic chemotherapies and/or novel immunotherapy treatments for MCC are allowed. A wash-out period of 2 weeks prior to aNK treatment will be required.
- ECOG performance status of 0-2.
- Voluntary written informed consent must be given before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
Key exclusion criteria (18 listed)
- Major surgery within 30 days before study entry.
- Any of the following clinical laboratory values at the time of enrollment:
- Liver function abnormalities as indicated by ongoing hepatic enzyme elevation (e.g. AST, ALT, GGT) > 2 x the ULN. Elevation related to direct tumor infiltration is allowed.
- Renal insufficiency as indicated by a creatinine level > 2 x the ULN.
- Myocardial infarction within 6 months prior to enrollment or New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled arrhythmias, or electrocardiographic evidence of acute ischemia or significant conduction system abnormalities in the opinion of the Investigator. Prior to study entry any known abnormality on an electrocardiogram (ECG) must be determined and documented by the Investigator to be not clinically significant to the patient participation in this study.
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 |
|---|---|---|
| aNK (NK-92)Also: NK-92, NeukoplastA natural killer cell line recovered from a patient with large granular lymphoma | Biological | aNK (NK-92) |
| aNK (NK-92) + N-803aNK - A natural killer cell line recovered from a patient with large granular lymphoma and N-803 - Recombinant human super agonist interleukin-15 (IL-15) complex | Biological | aNK (NK-92) + N-803 |
Primary outcome
Number of Participants With Progression Free Survival Rate at 4 Months
Time frame: 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Stage IIIB Merkel Cell Carcinoma
Active, not recruitingPhase 1
Tacrolimus, Nivolumab, and Ipilimumab in Treating Kidney Transplant Recipients With Selected Unresectable or Metastatic Cancers
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8
RecruitingPhase 1/2
Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Active, not recruitingPhase 3
Adjuvant Avelumab in Merkel Cell Cancer
Stage III Merkel Cell Carcinoma AJCC v8, Stage IIIB Merkel Cell Carcinoma AJCC v8
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.
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 aNK (NK-92) and aNK (NK-92) + N-803 in people with Stage IIIB Merkel Cell Carcinoma and Stage IV Merkel Cell Carcinoma, run by ImmunityBio, Inc. at 3 sites in United States.
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 6 inclusion and 18 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: stopped early, as of the sponsor's last update on 2 May 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 United States. 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?
Yes. Results are posted in the registry (first posted 2 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Progression Free Survival Rate at 4 Months (time frame: 4 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 2 May 2024.