Carcinoma, Renal CellPhase 1NCT02543645
A Study of Varlilumab and Atezolizumab in Patients With Advanced Cancer
A Phase 1 study testing Combination of Varlilumab and Atezolizumab in people with Carcinoma, Renal Cell and Kidney Diseases, run by Celldex Therapeutics at 4 sites in United States.
Trial summary
This is a study to determine the clinical benefit (how well the drug works), safety and tolerability of combining varlilumab and atezolizumab. Phase l of the study will enroll patients with a number of tumor types; Phase ll will enroll only patients with renal cell carcinoma (RCC).* *Note: This Study was terminated… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Renal Cell, Kidney Diseases, Kidney Neoplasms
- What is being tested?
- Combination of Varlilumab and Atezolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2015to 22 May 2017
- 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
- Unresectable stage lll or IV, histologically confirmed diagnosis of one of the following solid tumors:
- Phase l: Melanoma, RCC, triple negative breast cancer, bladder cancer, head and neck cancer or non-small cell lung cancer.
- Documented progressive disease based on radiographic, clinical or pathologic assessment during or subsequent to last therapy.
- Progressed or intolerant to at least 1 approved prior anticancer regimen.
- Measurable (target) disease.
- Life expectancy ≥ 12 weeks.
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- If of childbearing potential (male or female), agrees to practice an effective form of contraception during study treatment and for at least 90 days following last treatment dose.
- Must have available tumor tissue and consent to biopsy while on study.
- Patients with asymptomatic treated CNS metastasis may be enrolled after discussion with the Medical Monitor.
- ECOG of 0 or 1.
Who cannot join
- Prior therapy with varlilumab or with an anti-CD27 antibody.
- Previous treatment with anti-PD-1, anti-PD-L1 or anti-PD-L2 therapy.
- Use of any experimental immunotherapy.
- Receipt of anti-CTLA-4 targeted therapies or other checkpoint or co-stimulatory therapy within 3 months prior to start of study treatment.
- Chemotherapy within 21 days or at least 5 half-lives (whichever is shorter) prior to the planned state of study treatment.
- Systemic radiation therapy within 4 weeks, prior focal radiotherapy within 2 weeks, or radiopharmaceuticals (strontium, samarium) within 8 weeks prior to the first dose of study treatment.
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- Use of immunosuppressive medications within 4 weeks or systemic corticosteroids within 2 weeks prior to first dose of study treatment.
- Other prior malignancy, except for adequately treated basal or squamous cell skin cancer or in situ cancers; or any other cancer from which the patient has been disease-free for at least 3 years.
- Active, untreated CNS metastases.
- Active autoimmune disease or a documented history of autoimmune disease.
- Active diverticulitis.
- Significant cardiovascular disease including CHF, leptomeningeal disease, poorly controlled hypertension, or an MI within 6 months prior to dosing.
- Known alcohol or drug abuse.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Duke University Medical Center
Durham, North Carolina, 27710
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of California - San Francisco
San Francisco, California, 94550
About this study
Official title: A Phase l/ll, Open Label, Dose-escalation Study of Varlilumab (CDX-1127) in Combination With Atezolizumab (MPDL3280A, Anti-PD-L1) in Patients With Advanced Cancer
This is a study to determine the clinical benefit (how well the drug works), safety and tolerability of combining varlilumab and atezolizumab. Phase l of the study will enroll patients with a number of tumor types; Phase ll will enroll only patients with renal cell carcinoma (RCC).*
*Note: This Study was terminated prior to initiation of Phase II
Read the detailed description
Varlilumab is a fully human monoclonal antibody that binds to a molecule called CD27 found on certain immune cells and may act to promote anti-tumor effects.
Atezolizumab is an engineered anti-PD-L1 antibody.
This study will evaluate the safety, tolerability and efficacy of the anti-CD27 antibody varlilumab in combination with atezolizumab.
Eligible patients that enroll in the dose escalation portion of the study will be assigned to one of three dose levels of varlilumab in combination with 1200 mg of atezolizumab. The first phase of the study will enroll up to 18 patients and test the safety profile of the combination of varlilumab and atezolizumab in patients with various tumor types and determine which dose of varlilumab will be studied in Phase ll* of the study which will enroll only patients with RCC.
*Note: This Study was terminated prior to initiation of Phase II.
All patients enrolled in the study will be closely monitored to determine if there is a response to the treatment as well as for any side effects that may occur.
- Conditions
- Carcinoma, Renal Cell, Kidney Diseases, Kidney Neoplasms, Urogenital Neoplasms, Urologic Diseases, Urologic Neoplasms
- Being tested
- Combination of Varlilumab and Atezolizumab
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Diseases, Kidney Neoplasms, Urogenital Neoplasms, Urologic Diseases, Urologic Neoplasms, Neoplasms by Histologic Type, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of Varlilumab and AtezolizumabDrug
Treatment cycles are 12 weeks each with varlilumab and atezolizumab administered every 3 weeks. During the treatment phase of the study, eligible patients will receive varlilumab for up to 3 cycles (with a 4th cycle possible following discussion with the Medical Monitor). There is no limit on the number of cycles of atezolizumab. Patients may be discontinued from receiving study treatment (atezolizumab or varlilumab) based on the results of disease assessments or if experiencing side effects that make study therapy intolerable.
Phase l Dose: The planned dose of varlilumab will be dependent on the cohort assigned at enrollment. Varlilumab doses are 0.3 mg/kg, 1 mg/kg, or 3 mg/kg. The dose of atezolizumab is 1200 mg.
| Study group | Role | What they receive |
|---|---|---|
| Varlilumab and Atezolizumab | Experimental | Not described Receives: Drug: Combination of Varlilumab and Atezolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase l: Safety and tolerability of varlilumab in combination with atezolizumab as measured by incidence of drug related adverse events (AEs), serious drug related AEs, dose-limiting toxicities and laboratory test abnormalities.
Measured: Safety follow-up is 70 days from last study drug dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionApr 2017
- Study completion22 May 2017
Why it stopped: Portfolio re-prioritization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Renal CellStudies 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celldex Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02543645
- Sponsor's protocol ID
- CDX1127-06
- Status last verified
- Apr 2018
- First submitted
- 28 Aug 2015
- Last updated
- 30 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase l/ll, Open Label, Dose-escalation Study of Varlilumab (CDX-1127) in Combination With Atezolizumab (MPDL3280A, Anti-PD-L1) in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT02543645
- Acronym / sponsor ID
- CDX1127-06
- Conditions
- Carcinoma, Renal Cell, Kidney Diseases, Kidney Neoplasms, Urogenital Neoplasms, Urologic Diseases, Urologic Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Portfolio re-prioritization
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Celldex TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Study start
- Oct 2015
- Primary completion
- Apr 2017 (actual)
- Study completion
- 22 May 2017 (actual)
- First posted
- 7 Sep 2015 (estimated)
- 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 study to determine the clinical benefit (how well the drug works), safety and tolerability of combining varlilumab and atezolizumab. Phase l of the study will enroll patients with a number of tumor types; Phase ll will enroll only patients with renal cell carcinoma (RCC).*
*Note: This Study was terminated prior to initiation of Phase II
Detailed description
Varlilumab is a fully human monoclonal antibody that binds to a molecule called CD27 found on certain immune cells and may act to promote anti-tumor effects.
Atezolizumab is an engineered anti-PD-L1 antibody.
This study will evaluate the safety, tolerability and efficacy of the anti-CD27 antibody varlilumab in combination with atezolizumab.
Eligible patients that enroll in the dose escalation portion of the study will be assigned to one of three dose levels of varlilumab in combination with 1200 mg of atezolizumab. The first phase of the study will enroll up to 18 patients and test the safety profile of the combination of varlilumab and atezolizumab in patients with various tumor types and determine which dose of varlilumab will be studied in Phase ll* of the study which will enroll only patients with RCC.
*Note: This Study was terminated prior to initiation of Phase II.
All patients enrolled in the study will be closely monitored to determine if there is a response to the treatment as well as for any side effects that may occur.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Varlilumab and Atezolizumab | Experimental | Drug: Combination of Varlilumab and Atezolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Unresectable stage lll or IV, histologically confirmed diagnosis of one of the following solid tumors:
- Documented progressive disease based on radiographic, clinical or pathologic assessment during or subsequent to last therapy.
- Progressed or intolerant to at least 1 approved prior anticancer regimen.
- Measurable (target) disease.
- Life expectancy ≥ 12 weeks.
Key exclusion criteria (13 listed)
- Prior therapy with varlilumab or with an anti-CD27 antibody.
- Previous treatment with anti-PD-1, anti-PD-L1 or anti-PD-L2 therapy.
- Use of any experimental immunotherapy.
- Receipt of anti-CTLA-4 targeted therapies or other checkpoint or co-stimulatory therapy within 3 months prior to start of study treatment.
- Chemotherapy within 21 days or at least 5 half-lives (whichever is shorter) prior to the planned state of study treatment.
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 Varlilumab and AtezolizumabTreatment cycles are 12 weeks each with varlilumab and atezolizumab administered every 3 weeks. During the treatment phase of the study, eligible patients will receive varlilumab for up to 3 cycles (with a 4th cycle possible following discussion with the Medical Monitor). There is no limit on the number of cycles of atezolizumab. Patients may be discontinued from receiving study treatment (atezolizumab or varlilumab) based on the results of disease assessments or if experiencing side effects that make study therapy intolerable. Phase l Dose: The planned dose of varlilumab will be dependent on the cohort assigned at enrollment. Varlilumab doses are 0.3 mg/kg, 1 mg/kg, or 3 mg/kg. The dose of atezolizumab is 1200 mg. | Drug | Varlilumab and Atezolizumab |
Primary outcome
Phase l: Safety and tolerability of varlilumab in combination with atezolizumab as measured by incidence of drug related adverse events (AEs), serious drug related AEs, dose-limiting toxicities and laboratory test abnormalities.
Time frame: Safety follow-up is 70 days from last study drug dose.
Results and safety
The study was stopped early (reason given: Portfolio re-prioritization). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2018.
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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.
4 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 Combination of Varlilumab and Atezolizumab in people with Carcinoma, Renal Cell and Kidney Diseases, run by Celldex Therapeutics at 4 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 10 inclusion and 13 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 30 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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: Portfolio re-prioritization). 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?
Phase l: Safety and tolerability of varlilumab in combination with atezolizumab as measured by incidence of drug related adverse events (AEs), serious drug related AEs, dose-limiting toxicities and laboratory test abnormalities. (time frame: Safety follow-up is 70 days from last study drug dose.). 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 Apr 2018.