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Metastatic Pancreatic AdenocarcinomaPhase 2NCT04058964

Pembrolizumab and PEGPH20 in Treating Patients With Metastatic Pancreatic Cancer

A Phase 2 study testing Pegylated Recombinant Human Hyaluronidase PH20 and Pembrolizumab in people with Metastatic Pancreatic Adenocarcinoma and Stage IV Pancreatic Cancer AJCC v8, run by M.D. Anderson Cancer Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This phase II trial studies how well pembrolizumab and PEGPH20 work in treating patients with pancreatic cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pegylated Recombinant Human Hyaluronidase PH20 and Pembrolizumab
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
1 Feb 2020to 31 Oct 2022
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma based on pathology report
  • Be willing and able to provide written informed consent for the trial. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
  • Have at least one measurable lesion and one lesion available for biopsy (not the primary pancreatic lesion) based on RECIST 1.1. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
  • Have had prior treatment with first-line therapy for metastatic disease for at least 4 months, and have had a radiologic response or stable disease at the most recent imaging. Adjuvant therapy for resected disease will not count as first-line therapy. Therapies that are derivative of others (e.g. fluorouracil/leucovorin calcium/oxaliplatin [FOLFOX] vis-a-vis fuorouracil/irinotecan/leucovorin/oxaliplatin [FOLFIRINOX]) will be counted as a single line of treatment for the purpose of determining the number of prior therapies
  • Be willing to undergo a core biopsy or excisional biopsy of tumor from a metastatic site. Note that the biopsy itself will be done only after the patient has been found to meet all other inclusion/exclusion criteria and the patient is otherwise prepared to start therapy
  • Be willing to provide (and have available) archival tissue from a surgical or biopsy specimen obtained PRIOR to the most recent chemotherapy
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  • Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale
  • Demonstrate adequate organ function. Specimens must be collected within 10 days prior to the start of trial treatment
  • Female subjects of childbearing potential must have a negative urine or serum pregnancy test at screening (prior to biopsy) and again within 24 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
  • Male and female subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of trial therapy through 120 days after the last dose of trial therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject. Acceptable methods of contraception are as follows:
  • Single method (1 of the following is acceptable): intrauterine device (IUD), vasectomy of a female subject's male partner, contraceptive rod implanted into the skin
  • Combination method (requires use of 2 of the following): diaphragm with spermicide (cannot be used in conjunction with cervical cap/spermicide), cervical cap with spermicide (nulliparous women only), contraceptive sponge (nulliparous women only), male condom or female condom (cannot be used together), hormonal contraceptive: oral contraceptive pill (estrogen/ progestin pill or progestin-only pill), contraceptive skin patch, vaginal contraceptive ring, or subcutaneous (SC) contraceptive injection

Who cannot join

  • Has pancreatic tumor other than adenocarcinoma, including: acinar cell carcinoma, pancreaticoblastoma, malignant cystic neoplasms, endocrine neoplasms, squamous cell carcinoma, ampulla of Vater, periampullary, duodenal, or common bile duct malignancies
  • Has had more than one line of systemic chemotherapy for metastatic disease
  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment
  • Has had prior treatment with PEGPH20
  • Has received prior systemic anti-cancer therapy that includes investigational agents within 2 weeks prior to treatment
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
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  • Had a solid organ or hematologic transplant
  • Has active autoimmune disease that has required systemic treatment in past 3 months (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Patients with autoimmune colitis (eg Crohn's disease) will be excluded. Any relevant diseases not listed here are to be discussed with the study supporters. Replacement hormone therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed
  • Has a diagnosed additional malignancy within 1 year prior to first dose of study treatment, with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or curatively resected tumors of low invasive potential (e.g. in situ cervical and/or breast cancers)
  • Has a history of central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has a history of (non-infectious) pneumonitis that required oral or IV steroids or currently has pneumonitis
  • Has an active infection requiring systemic therapy
  • Chronic use of steroids for pain or emesis management
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment
  • Has received prior immunotherapy including anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or with an agent directed to another stimulatory or co-inhibitory T cell receptor (eg, CTLA-4, OX-40, CD137), or has previously participated in Merck pembrolizumab or PEGPH20 clinical trials
  • Has a known history of human immunodeficiency virus (HIV) infection (HIV 1/2 antibodies) (HIV testing is required during screening)
  • Has a history of the following liver diseases: hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive), hepatitis C (defined as detectable hepatitis C virus [HCV] ribonucleic acid [RNA]), primary biliary cholangitis, primary sclerosing cholangitis, history of immune mediated cholangitis. Of note, patients with a history of bacterial cholangitis are eligible if the infection has been fully resolved prior to the screening visit. An exception is made for hepatitis C patients who have undergone treatment and who have negative serologic testing for at least one year
  • Has received a live vaccine within 30 days prior to the first dose of trial drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist) are live attenuated vaccines and are not allowed
  • Has a known history of active TB (Bacillus tuberculosis)
  • Is unable to tolerate a contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI) for staging/restaging purposes
  • Has not recovered (i.e., grade 1 or at baseline) from adverse events (AEs) due to chemotherapy (neuropathy and alopecia are excluded)
  • Has clinical evidence of a deep vein thrombosis (DVT), pulmonary embolism (PE), or other known thrombotic event present during the screening period. Of note - this does not apply to splanchnic vein (eg portal / superior mesenteric vein) thrombosis that, in the opinion of the primary investigator, are primarily associated with the anatomic location of the underlying disease
  • Requires Megace (medroxyprogesterone acetate)
  • In the estimation of the treating physician or primary investigator, have had a clinical deterioration of their ECOG performance within the month prior to enrollment
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
  • Has unstable angina, new onset angina within the last 3 months, myocardial infarction within the last 6 months, and current congestive heart failure New York Heart Association class III or higher. Additionally, subjects with myocardial infarction or atrial fibrillation within the past 12 months are excluded
  • Has a history of a cerebrovascular accident or transient ischemic attack
  • Known clinically significant pre-existing carotid artery disease
  • Has a history of active bleeding requiring transfusion within a 3 month period prior to screening
  • Known allergy/intolerance to hyaluronidase or dexamethasone
  • Has severe hypersensitivity (>= grade 3) to pembrolizumab and/or any of its excipients
  • Contraindication to heparin or non-steroidal anti-inflammatory drugs (NSAIDs)
  • Known cases of drug-induced hepatobiliary toxicities (other than a radiological finding of fatty liver)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Pilot Study to Assess the Efficacy and Safety Effects of Pembrolizumab and PEGPH20 (Pegvorhyaluronidase Alfa) in Patients With Metastatic Pancreatic Cancer

This phase II trial studies how well pembrolizumab and PEGPH20 work in treating patients with pancreatic cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. PEGPH20 is an enzyme that breaks down hyaluronic acid coating tumor cells which may inhibit growth of tumor cells. Giving pembrolizumab and PEGPH20 may work better in treating patients with pancreatic cancer compared to pembrolizumab alone.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess the progression free survival duration of patients treated with the combination of pegylated recombinant human hyaluronidase PH20 (PEGPH20) and pembrolizumab.

SECONDARY OBJECTIVES:

  1. To assess the safety and tolerability of the combination of PEGPH20 and pembrolizumab.

EXPLORATORY OBJECTIVES:

  1. To evaluate objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) and Immune-Modified Response Evaluation Criteria in Solid Tumors (iRECIST) criteria, duration of response (DOR), disease control rate (DCR), time to progression (TTP) and progression-free survival (PFS) per RECIST and iRECIST as assessed by M.D. Anderson investigators and overall survival (OS) of the combination of pembrolizumab and PEGPH20.

II. To explore the association between PD-L1 expression by immunohistochemistry (IHC), shed PD-L1 level, hyaluronan (HA) levels, somatic gene expression profiling and antitumor efficacy of the combination of pembrolizumab and PEGPH20 based on RECIST 1.1 as well as OS.

III. To explore the relationship between genomic variation and response to study treatment.

IV. To examine the effect of pembrolizumab and PEGPH20 on immune cell infiltration into tumor.

  1. To explore the effect of PEGPH20 on serum HA levels, and to compare changes in serum HA with clinical efficacy.

VI. To determine the impact of the combination of pembrolizumab and PEGPH20 on circulating immune cells.

OUTLINE:

Patients receive pembrolizumab intravenously (IV) over 10 minutes on day 1 and pegylated recombinant human hyaluronidase PH20 subcutaneously (SC) on days 1, 8, and 15. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then every 9 and 12 weeks.

Being tested
Pegylated Recombinant Human Hyaluronidase PH20, Pembrolizumab
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • Pegylated Recombinant Human Hyaluronidase PH20Biological

    Also called PEGPH20, Pegylated Recombinant Human PH20, Pegylated rHuPH20, PH20

    Given SC

  • PembrolizumabBiological

    Also called Keytruda, Lambrolizumab, MK-3475, SCH 900475

    Given IV

Study groups in NCT04058964
Study groupRoleWhat they receive
Treatment (pembrolizumab, PEGPH20)ExperimentalPatients receive pembrolizumab IV over 10 minutes on day 1 and pegylated recombinant human hyaluronidase PH20 SC on days 1, 8, and 15. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
Receives: Biological: Pegylated Recombinant Human Hyaluronidase PH20; Biological: Pembrolizumab

What is being measured

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

  1. Progression free survival (PFS)

    Descriptive statistics including with 90% confidence interval will be computed.

    Measured: Up to 1 year

Secondary outcomes (1)

  1. Incidence of adverse events

    Descriptive statistics including with 90% confidence interval will be computed.

    Measured: Up to 30 days post treatment

Timeline

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

  1. First posted16 Aug 2019
  2. Study start1 Feb 2020 (estimated)
  3. Primary completion31 Oct 2022 (estimated)
  4. Study completion31 Oct 2022 (estimated)

Why it stopped: Study withdrawn by supporter

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04058964
Sponsor's protocol ID
2018-0342
Other IDs
NCI-2019-04856, 2018-0342, P30CA016672
Status last verified
Mar 2020
First submitted
14 Aug 2019
Last updated
13 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pegylated Recombinant Human Hyaluronidase PH20 and Pembrolizumab in people with Metastatic Pancreatic Adenocarcinoma and Stage IV Pancreatic Cancer AJCC v8, run by M.D. Anderson Cancer 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 12 inclusion and 34 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 13 Mar 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) (time frame: Up to 1 year). 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 NCT04058964.

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 13 Mar 2020.

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