CancerPhase 2NCT04016116
Dual PD-1 and JAK2 Inhibition in Hematological Malignancies
A Phase 2 study testing Pembrolizumab and Ruxolitinib in people with Cancer and Hematological Malignancy, run by NYU Langone Health at 1 site in United States.
Trial summary
Pembrolizumab will have significant clinical activity in patients with Intermediate and high risk MF, advanced PV who have been resistant, failed or are intolerant to JAK2 inhibitor therapy and the activity may be enhanced in combination with JAK2 inhibition by Ruxolitinib; similarly MDS/MPN and CMML patients for who… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cancer, Hematological Malignancy
- What is being tested?
- Pembrolizumab and Ruxolitinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2019to Dec 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- advanced progressive MPNs, defined as intermediate and high risk MF or advanced PV resistant, failed or intolerant to JAK2 inhibitor therapy requiring medical therapy and patients with MDS/MPN Overlap and CMML having failed or for whom there are no standard therapies are available, are eligible. Patients will be allocated to one of two treatment arms:
- Pembrolizumab
- Pembrolizumab plus JAK2 inhibitor Ruxolitinib
- Patients with relapsed* or refractory* Hodgkin lymphoma (HL) who progress on PD-1 inhibitory treatment after achieving a partial response (PR) or complete response (CR) or stable disease (SD) or who are non-responsive to PD-1 inhibitory therapy. Patients must have failed appropriate standard treatment options.
- Relapsed: disease progression after most recent therapy
- Refractory: failure to achieve CR or PR to most recent therapy
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- -The following laboratory values obtained less than 7 days prior to registration.
- Total bilirubin ≤ 1.5 x Upper Limit normal (ULN) (except Gilbert's syndrome or known hemolysis or leukemic infiltration)
- AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN or < 5 x ULN if organ involvement
- Alkaline Phosphatase < 5 x ULN
- Serum creatinine ≤ 2 x ULN or 24 hour Cr clearance >60ml/min
- Hematological inclusion criteria for:
- MPN: -Platelet count ≥50,000/μL; Absolute neutrophil count (ANC) ≥250/μL
- Hematological inclusion criteria for:
- MPN: -Platelet count ≥50,000/μL ;Absolute neutrophil count (ANC) ≥250/μL
- MDS/MPN Overlap, CMML: Platelet count ≥25,000/μL; Absolute neutrophil count (ANC) ≥250/μ
- HL-Platelet count ≥75,000/μL; Absolute neutrophil count (ANC) ≥1000/μL (800/ μL if marrow disease involvement; ECOG Performance Status (PS) 0 or 1 (Appendix I)
- Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
- Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
Who cannot join
- Uncontrolled intercurrent illness including, but not limited to active uncontrolled infection, or psychiatric illness/social situations that would limit compliance with study requirements.
- Any of the following prior therapies:
- Cytotoxic Chemotherapy less than 14 days prior to registration
- Immunotherapy less than 14 days prior to registration
- Biologic therapy (i.e. antibody therapies) less than 28 days prior to registration (see also 3.32)
- Radiation therapy less than 14 days prior to registration
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- Targeted therapies (i.e. kinase inhibitors, less than 7 days or 5 half-life's whichever is shorter)
- Hydroxyurea (HU) is allowed for blast count control throughout study
- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm ≤ 14 days prior to registration
- Active uncontrolled CNS leukemia. NOTE: Positive (cyto)pathology is allowed and patient can receive intrathecal chemotherapy
- Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy.
- Hypersensitivity to Ruxolitinib or any of its excipients.
- Acute Myeloid Leukemia with > 30% blasts in the bone marrow of peripheral blood
- Major surgery ≤ 28 days prior to treatment
- Clinically significant heart disease
- Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
- Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
- Has a known additional malignancy that is progressing or requires active treatment.
- Has active autoimmune disease that has required systemic treatment in the past 2
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception
- Patients who have undergone an allogeneic stem cell transplantation within 5 years from registration are excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Study of PD-1 Inhibition With Pemrolizumab Alore or Combined With JAK 2 Inhibition in Myeloproliferative Neoplasm and Hodgkin's Lymphoma
Pembrolizumab will have significant clinical activity in patients with Intermediate and high risk MF, advanced PV who have been resistant, failed or are intolerant to JAK2 inhibitor therapy and the activity may be enhanced in combination with JAK2 inhibition by Ruxolitinib; similarly MDS/MPN and CMML patients for who no standard therapies are available will exhibit responses to PD-1 or dual JAK2 and PD-1 treatment.
Adding JAK2 inhibitor Ruxolitinib to Pembrolizumab will have significant activity in patients with advanced, progressive HL who failed single agent PD-1 inhibition.
- Conditions
- Cancer, Hematological Malignancy
- Being tested
- Pembrolizumab, Ruxolitinib
- Medical subject headings
- Neoplasms, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called keytruda
Pembrolizumab IV every 3 weeks
RuxolitinibDrug
Also called jakafi
Ruxolitinib po days 1-21
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab (Cohort 1) | Experimental | Pembrolizumab IV every 3 weeks (Cohort 1: Advanced progressive MPNs) Receives: Drug: Pembrolizumab |
| Pembrolizumab + Ruxolitinib | Experimental | Pembrolizumab IV every 3 weeks \& Ruxolitinib po days 1-21 (Cohort 1: Advanced progressive MPNs) Receives: Drug: Pembrolizumab; Drug: Ruxolitinib |
| Pembrolizumab + Ruxolitinib (Cohort 2) | Experimental | Pembrolizumab IV every 3 weeks \& Ruxolitinib po days 1-21 (Cohort 2, unresponsive to PD-1) Receives: Drug: Pembrolizumab; Drug: Ruxolitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) measured using the Kaplan-Meier Method
Progression free survival (PFS) is defined as the time from randomization or enrollment registration to the earliest date of documentation of disease progression or death.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study startDec 2019 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: PI left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raoul Tibes, MD, Principal investigator, New York Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016116
- Sponsor's protocol ID
- 17-01435
- Status last verified
- May 2020
- First submitted
- 27 Jun 2019
- Last updated
- 27 May 2020
- Results posted
- No
- 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 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of PD-1 Inhibition With Pemrolizumab Alore or Combined With JAK 2 Inhibition in Myeloproliferative Neoplasm and Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT04016116
- Acronym / sponsor ID
- 17-01435
- Conditions
- Cancer, Hematological Malignancy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left the institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Dec 2019 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 11 Jul 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.
Pembrolizumab will have significant clinical activity in patients with Intermediate and high risk MF, advanced PV who have been resistant, failed or are intolerant to JAK2 inhibitor therapy and the activity may be enhanced in combination with JAK2 inhibition by Ruxolitinib; similarly MDS/MPN and CMML patients for who no standard therapies are available will exhibit responses to PD-1 or dual JAK2 and PD-1 treatment.
Adding JAK2 inhibitor Ruxolitinib to Pembrolizumab will have significant activity in patients with advanced, progressive HL who failed single agent PD-1 inhibition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab (Cohort 1) | Experimental | Drug: PembrolizumabPembrolizumab IV every 3 weeks (Cohort 1: Advanced progressive MPNs) |
| Pembrolizumab + Ruxolitinib | Experimental | Drug: Pembrolizumab, Drug: RuxolitinibPembrolizumab IV every 3 weeks \& Ruxolitinib po days 1-21 (Cohort 1: Advanced progressive MPNs) |
| Pembrolizumab + Ruxolitinib (Cohort 2) | Experimental | Drug: Pembrolizumab, Drug: RuxolitinibPembrolizumab IV every 3 weeks \& Ruxolitinib po days 1-21 (Cohort 2, unresponsive to PD-1) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- advanced progressive MPNs, defined as intermediate and high risk MF or advanced PV resistant, failed or intolerant to JAK2 inhibitor therapy requiring medical therapy and patients with MDS/MPN Overlap and CMML having failed or for whom there are no standard therapies are available, are eligible. Patients will be allocated to one of two treatment arms:
- Patients with relapsed* or refractory* Hodgkin lymphoma (HL) who progress on PD-1 inhibitory treatment after achieving a partial response (PR) or complete response (CR) or stable disease (SD) or who are non-responsive to PD-1 inhibitory therapy. Patients must have failed appropriate standard treatment options.
- Relapsed: disease progression after most recent therapy
- Refractory: failure to achieve CR or PR to most recent therapy
- -The following laboratory values obtained less than 7 days prior to registration.
Key exclusion criteria (25 listed)
- Uncontrolled intercurrent illness including, but not limited to active uncontrolled infection, or psychiatric illness/social situations that would limit compliance with study requirements.
- Any of the following prior therapies:
- Active uncontrolled CNS leukemia. NOTE: Positive (cyto)pathology is allowed and patient can receive intrathecal chemotherapy
- Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy.
- Hypersensitivity to Ruxolitinib or any of its excipients.
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 |
|---|---|---|
| PembrolizumabAlso: keytrudaPembrolizumab IV every 3 weeks | Drug | Pembrolizumab (Cohort 1), Pembrolizumab + Ruxolitinib, Pembrolizumab + Ruxolitinib (Cohort 2) |
| RuxolitinibAlso: jakafiRuxolitinib po days 1-21 | Drug | Pembrolizumab + Ruxolitinib, Pembrolizumab + Ruxolitinib (Cohort 2) |
Primary outcome
Progression Free Survival (PFS) measured using the Kaplan-Meier Method
Time frame: 6 Months
Progression free survival (PFS) is defined as the time from randomization or enrollment registration to the earliest date of documentation of disease progression or death.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
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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.
Raoul Tibes, MD principal investigator
New York Langone Medical Center
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 Pembrolizumab and Ruxolitinib in people with Cancer and Hematological Malignancy, run by NYU Langone Health at 1 site 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 20 inclusion and 25 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: withdrawn, as of the sponsor's last update on 27 May 2020. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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 (PFS) measured using the Kaplan-Meier Method (time frame: 6 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 27 May 2020.