AzTrials
AzTrials

LymphomaPhase 1/2NCT02408042

Study of Pembrolizumab With Chemotherapy in Patients With Advanced Lymphoma (PembroHeme)

A Phase 1/2 study testing Pembrolizumab, Etoposide and Ifosfamide in people with Lymphoma and Hodgkin's Lymphoma, run by Western Regional Medical Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

To determine the recommended phase 2 dose of chemotherapy in combination with Pembrolizumab in subjects with advanced lymphoma and determine the complete response rate. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pembrolizumab, Etoposide and Ifosfamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Apr 2015to Nov 2015
Phase
Phase 1/2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient at least 18 years old and has definitive histologically or cytologically confirmed: classical Hodgkin lymphoma (HL) or diffuse large B-Cell lymphoma (DLBCL) non-Hodgkin lymphoma (NHL).
  • Patient has one or more metastatic lesions >1.5 cm as defined by lymphoma response criteria by PET-CT scan. If CT scan is needed for clarification of findings on PET-CT it may be done additionally. Tumor sites that are considered measureable must not have received prior radiation therapy.
  • Patients can be enrolled only on one of the treatment arms on this trial.
  • The investigator will select the appropriate treatment arm for the patient with the following requirements: (a) Patients cannot have had prior progression or intolerance on the single agent chemotherapy and then enrolled on an arm with that same single agent chemotherapy plus pembro (b) The chemotherapy on the arm selected must be considered standard of care or listed in www.nccn.org for that cancer type.
  • Have recovered from acute toxicities of prior treatment:
  • > 3 weeks must have elapsed since receiving any investigational agent.
Show all 15Show fewer
  • > 2 weeks must have elapsed since receiving any radiotherapy, or ≥ 3 weeks or 5 half-lives whichever is shorter for treatment with cytotoxic or biologic agents ( ≥ 6 weeks for mitomycin or nitrosoureas). Chronic treatment with non-investigational gonadotropin-releasing hormone analogs or other hormonal or supportive care is permitted.
  • Patient has adequate biological parameters as demonstrated by the following blood counts at time of screening:
  • Absolute neutrophil count (ANC) > 1000/ microliter, platelet count ≥ 75,000/ microliter, hemoglobin ≥ 9 g/dL. Subject can be given packed red blood cell transfusion.
  • Calculated creatinine clearance > 50 ml/min by Cockroft-Gault equation, total bilirubin 1.5 times the upper limit of normal (ULN) range, AST/ALT ≤ 3 times the upper limit of normal (ULN) range.
  • Thyroid stimulating hormone (TSH) within institutional normal limits. If TSH is above the upper limit of normal range, then a free T4 within institutional normal limits is acceptable.
  • At least 100 days must have elapsed in subjects that had a prior autologous transplant.
  • Resolution of prior systemic therapy non-hematologic AE to grade ≤ 2 (except alopecia or correctable electrolyte abnormality with supplementation)
  • Patient has a Karnofsky performance status (KPS) ≥ 60.
  • Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must be willing to use an acceptable contraceptive method (abstinence, oral contraceptive or double barrier method) for the duration of the study and for 4 months following the last dose of Pembrolizumab, brentuximab vedotin, or for 2 years following the last dose of chemotherapy on this trial, and must have a negative urine or serum pregnancy test within 2 weeks prior to beginning treatment on this trial. If a female subject or female partner of a male subject becomes pregnant during this period then patient will be recommended to seek appropriate obstetric care. The study will not be monitoring subjects or female partners of subjects for pregnancy after the last dose of study drug or chemotherapy.

Who cannot join

  • Active clinically serious infection > Grade 2.
  • Serious non-healing wound, ulcer, or bone fracture.
  • Patient has known brain metastases.
  • Patient has with myelodysplasia, polycythemia vera, idiopathic thrombocythemia, myelofibrosis, or acute leukemia.
  • Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements.
  • Patient has known active infection with HIV, hepatitis B, or hepatitis C (patients will be required to be tested for the presence of such viruses prior to therapy on this protocol).
Show all 14Show fewer
  • Ejection fraction measuring less than 45% (measurement of ejection fraction is required only for subjects with prior anthracycline exposure).
  • Requiring daily corticosteroid dose ≥ 10 mg prednisone or equivalent per day.
  • Patient has undergone major surgery, other than diagnostic surgery (e.g., surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day 1 of treatment in this study.
  • Patient has a history of allergy or hypersensitivity to any of the study drugs or any of their excipients, or the patient exhibits any of the events outlined in the Contraindication or Special Warnings and Precautions sections of the product or comparator SmPC or Prescribing Information.
  • Patient has serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the patient's safety or the study data integrity.
  • Patient will be receiving any other anti-cancer therapy during participation in this trial.
  • Prior treatment with Pembrolizumab is not allowed. Prior receipt of other PD-1 inhibitors or PD-L1 inhibitors is allowed.
  • Active or prior documented autoimmune disease requiring systemic treatment within the past 2 years.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cancer Treatment Center of America @ Western Regional Medical Center

    Goodyear, Arizona, 85338

Other trials in United States

About this study

Official title: A Phase Ib/II Study of Pembrolizumab With Chemotherapy in Patients With Advanced Lymphoma (PembroHeme)

To determine the recommended phase 2 dose of chemotherapy in combination with Pembrolizumab in subjects with advanced lymphoma and determine the complete response rate.

Medical subject headings
Lymphoma, Hodgkin Disease, Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02408042
Study groupRoleWhat they receive
RICE and PembrolizumabActive comparatornon-Hodgkin's lymphoma patients requiring 2nd line or beyond therapy and eligible to receive RICE (rituximab, ifosfamide, carboplatin, and etoposide)
Receives: Drug: Pembrolizumab; Drug: Etoposide; Drug: Ifosfamide; Drug: Mesna; Drug: Carboplatin; Drug: Rituximab
ICE and PembrolizumabActive comparatorclassical Hodgkin's lymphoma requiring 2nd line or beyond therapy and eligible to receive ICE (ifosfamide, carboplatin, and etoposide)
Receives: Drug: Pembrolizumab; Drug: Etoposide; Drug: Ifosfamide; Drug: Mesna; Drug: Carboplatin
brentuximab vedotin and PembrolizumabActive comparatorclassical Hodgkin's lymphoma that have progressed after high-dose chemotherapy with autologous stem cell rescue or progressed on at least 2 lines of therapy and are eligible to receive brentuximab vedotin
Receives: Drug: Pembrolizumab; Drug: Brentuximab vedotin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determine the recommended phase 2 dose (RP2D) of chemotherapy in combination with pembrolizumab (pembro) in subjects with advanced lymphoma and complete remission by Revised Response Criteria for Malignant Lymphoma.

    Measured: up to 12 weeks

Secondary outcomes (5)

  1. Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03

    Measured: up to 12 months

  2. Response rate by immune-related response criteria (irRC)

    Measured: 12 weeks

  3. Overall survival (OS) and progression-free survival (PFS)

    Measured: up to 12 months

  4. Changes in number of copies of circulating tumor DNA in patients enrolled on this study

    Measured: up to 12 months

  5. Changes to pixel intensity identified on imaging that is done per routine practice

    Measured: up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionNov 2015
  4. Study completionNov 2015

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02408042
Sponsor's protocol ID
WG2014035
Status last verified
Dec 2015
First submitted
25 Mar 2015
Last updated
27 Jun 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Pembrolizumab, Etoposide and Ifosfamide in people with Lymphoma and Hodgkin's Lymphoma, run by Western Regional Medical Center 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 15 inclusion and 14 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 Jun 2017. 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 combined 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.

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?

Determine the recommended phase 2 dose (RP2D) of chemotherapy in combination with pembrolizumab (pembro) in subjects with advanced lymphoma and complete remission by Revised Response Criteria for Malignant Lymphoma. (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02408042.

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 Jun 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in