Classical Hodgkin LymphomaPhase 1NCT03471351
Safety and Efficacy Study of Tenalisib (RP6530) in Combination With Pembrolizumab in Relapsed or Refractory cHL
A Phase 1 study testing Tenalisib and Pembrolizumab in people with Classical Hodgkin Lymphoma, run by Rhizen Pharmaceuticals SA at 3 sites in United States.
Trial summary
To characterize safety, tolerability and to establish the maximum tolerated dose (MTD) for Tenalisib in combination with Pembrolizumab in patients with cHL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Classical Hodgkin Lymphoma
- What is being tested?
- Tenalisib and Pembrolizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 Jul 2018to 13 Feb 2019
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years on the day of signing informed consent.
- Histologically confirmed diagnosis of cHL.
- Disease status as defined as.
- Refractory patients who are naïve to anti-PD-1/PDL-1 therapy OR Relapsed after 3 or more lines of therapies; and are naïve to anti-PD-1/PDL-1 therapy OR
- Patients currently on Pembrolizumab and achieve a less than complete response
- Must have ECOG performance status of 0 or 1
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- At least one bi-dimensional measurable lesion with minimum measurement of > 15 mm in the longest diameter.
- Toxicities related to prior therapy must have returned to Grade 1 or less, except for alopecia.
- Adequate bone marrows, liver and renal function as assessed by the following laboratory requirements. Hemoglobin ≥8.0 g/dL (may not be transfused or treated with erythropoietin in preceding week to maintain or exceed this level)
- Absolute neutrophil count (ANC) ≥1,000/µL
- Platelet count ≥75,000/μL
- Total bilirubin ≤1.5 times the ULN (or ≤3 x ULN, if patient has Gilbert syndrome)
- ALT and AST ≤2.5 x ULN
- Serum creatinine ≤ 1.5 x ULN or CrCl > 60 ml/min (Cockcroft-Gault formula)
- Use of an effective means of contraception for women of childbearing potential and men with partners of childbearing potential
- Provide written informed consent prior to any study-specific screening procedures.
- Willingness and capability to comply with the requirements of the study.
Who cannot join
- Patient receiving anticancer therapy (e.g. chemotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization) ≤3 weeks or 5 half-lives (whichever is shorter) prior to C1D1,
- Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti CTLA-4 antibody or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
- Radiotherapy within the last 21 days prior to C1D1 (limited field palliative radiation is allowed if ≥ 14 days prior to C1D1);
- Investigational drug therapy outside of this trial during or within 3 weeks prior to C1D1.
- Patients with Allo-SCT on active GVHD or immunosuppression therapy within 3 months prior to C1D1.
- Patient with active autoimmune disease or any medical condition requiring the use of systemic immunosuppressive medications .
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- Pregnancy or lactation.
- Known clinically active CNS involvement.
- Evidence of active Hepatitis B, active Hepatitis C infection (HCV) or cytomegalovirus (CMV) or known history of HIV.
- Subjects with concomitant second malignancies
- Patient with any active immune toxicity of Grade 1 or greater or any other severe or Grade 3 treatment-related adverse event.
- History of Grade 4 anaphylactic reaction to monoclonal antibody therapy.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Chicago
Chicago, Illinois, 60637
Rhizen Pharmaceuticals investigational trial site; Karmanos Cancer Institute,
Detroit, Michigan, 48201
University of Washington
Seattle, Washington, 98109
About this study
Official title: An Open Label, Phase I/II Study to Evaluate the Safety and Efficacy of RP6530, a Novel PI3K δ/γ Dual Inhibitor Given in Combination With an Anti-PD-1 Therapy, Pembrolizumab in Adult Patients With Relapsed or Refractory cHL
To characterize safety, tolerability and to establish the maximum tolerated dose (MTD) for Tenalisib in combination with Pembrolizumab in patients with cHL.
- Conditions
- Classical Hodgkin Lymphoma
- Being tested
- Tenalisib, Pembrolizumab
- Keywords
- Hodgkin lymphoma, RP6530, Pembrolizumab, Tenalisib
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TenalisibDrug
Also called RP6530
Tenalisib, BID, orally and Pembrolizumab 200 mg IV Q3W
PembrolizumabBiological
Tenalisib, BID, orally and Pembrolizumab 200 mg IV Q3W
| Study group | Role | What they receive |
|---|---|---|
| Tenalisib+Pembrolizumab | Experimental | Participants receive Tenalisib in escalating doses Orally BID and pembrolizumab as a fixed dose intravenously (IV) in Escalation and Expansion. Receives: Drug: Tenalisib; Biological: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) for Tenalisib in combination with Pembrolizumab in patients with cHL
The MTD was defined as the highest dose level at which no more than 1 in 6 participants experienced a dose-limiting toxicity (DLT) during the first 21-day cycle of treatment.
Measured: 21 days
Secondary outcomes (6)
Maximum observed plasma concentration (Cmax)
Assessment of Cmax in subjects treated with RP6530 and pembrolizumab combination
Measured: 21 days
Overall response rate (ORR) with Tenalisib and Pembrolizumab combination
No of patients with partial and complete response
Measured: 12 weeks
Duration of Response (DoR) with Tenalisib and Pembrolizumab combination
The time period from the response achieved in patient until the disease progression.
Measured: 12 weeks
Progression free survival (PFS) with Tenalisib and Pembrolizumab combination
Progression-free survival was defined as the time from enrollment in the study to disease progression
Measured: 12 weeks
Conversion Rate with Tenalisib and Pembrolizumab combination
Defined as improved outcome status (i.e Improve from PR to CR or from SD to PR)
Measured: 12 weeks
Proportion of patients achieving CR and PR with Tenalisib and Pembrolizumab combination
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start18 Jul 2018
- Primary completion13 Feb 2019
- Study completion13 Feb 2019
Why it stopped: At this point, the current study in HL does not fit into clinical development and regulatory strategy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Classical Hodgkin LymphomaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhizen Pharmaceuticals SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471351
- Sponsor's protocol ID
- RP6530+Pembrolizumab-1701
- Status last verified
- Dec 2019
- First submitted
- 15 Feb 2018
- Last updated
- 27 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Phase I/II Study to Evaluate the Safety and Efficacy of RP6530, a Novel PI3K δ/γ Dual Inhibitor Given in Combination With an Anti-PD-1 Therapy, Pembrolizumab in Adult Patients With Relapsed or Refractory cHL
- ClinicalTrials.gov ID
- NCT03471351
- Acronym / sponsor ID
- RP6530+Pembrolizumab-1701
- Conditions
- Classical Hodgkin Lymphoma
- Keywords
- Hodgkin lymphoma, RP6530, Pembrolizumab, Tenalisib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: At this point, the current study in HL does not fit into clinical development and regulatory strategy.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Rhizen Pharmaceuticals SAIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- 13 Feb 2019 (actual)
- Study completion
- 13 Feb 2019 (actual)
- First posted
- 20 Mar 2018 (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.
To characterize safety, tolerability and to establish the maximum tolerated dose (MTD) for Tenalisib in combination with Pembrolizumab in patients with cHL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tenalisib+Pembrolizumab | Experimental | Drug: Tenalisib, Biological: PembrolizumabParticipants receive Tenalisib in escalating doses Orally BID and pembrolizumab as a fixed dose intravenously (IV) in Escalation and Expansion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age ≥18 years on the day of signing informed consent.
- Histologically confirmed diagnosis of cHL.
- Disease status as defined as.
- Must have ECOG performance status of 0 or 1
- At least one bi-dimensional measurable lesion with minimum measurement of > 15 mm in the longest diameter.
Key exclusion criteria (12 listed)
- Patient receiving anticancer therapy (e.g. chemotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization) ≤3 weeks or 5 half-lives (whichever is shorter) prior to C1D1,
- Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti CTLA-4 antibody or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
- Radiotherapy within the last 21 days prior to C1D1 (limited field palliative radiation is allowed if ≥ 14 days prior to C1D1);
- Investigational drug therapy outside of this trial during or within 3 weeks prior to C1D1.
- Patients with Allo-SCT on active GVHD or immunosuppression therapy within 3 months prior to C1D1.
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 |
|---|---|---|
| TenalisibAlso: RP6530Tenalisib, BID, orally and Pembrolizumab 200 mg IV Q3W | Drug | Tenalisib+Pembrolizumab |
| PembrolizumabTenalisib, BID, orally and Pembrolizumab 200 mg IV Q3W | Biological | Tenalisib+Pembrolizumab |
Primary outcome
Maximum tolerated dose (MTD) for Tenalisib in combination with Pembrolizumab in patients with cHL
Time frame: 21 days
The MTD was defined as the highest dose level at which no more than 1 in 6 participants experienced a dose-limiting toxicity (DLT) during the first 21-day cycle of treatment.
6 secondary outcomes
Maximum observed plasma concentration (Cmax)
Time frame: 21 days
Overall response rate (ORR) with Tenalisib and Pembrolizumab combination
Time frame: 12 weeks
Duration of Response (DoR) with Tenalisib and Pembrolizumab combination
Time frame: 12 weeks
Progression free survival (PFS) with Tenalisib and Pembrolizumab combination
Time frame: 12 weeks
Conversion Rate with Tenalisib and Pembrolizumab combination
Time frame: 12 weeks
Proportion of patients achieving CR and PR with Tenalisib and Pembrolizumab combination
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: At this point, the current study in HL does not fit into clinical development and regulatory strategy.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 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.
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 1 study testing Tenalisib and Pembrolizumab in people with Classical Hodgkin Lymphoma, run by Rhizen Pharmaceuticals SA 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 17 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: stopped early, as of the sponsor's last update on 27 Dec 2019. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 stopped early (reason given: At this point, the current study in HL does not fit into clinical development and regulatory strategy.). Results are not available in the source record.
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?
Maximum tolerated dose (MTD) for Tenalisib in combination with Pembrolizumab in patients with cHL (time frame: 21 days). 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 Dec 2019.