ClinicalTrials.gg
TerminatedNCT03371979Updated Oct 28, 2026Results posted

Pegzilarginase and Pembrolizumab for Extensive Disease Small Cell Lung Cancer

A Phase 1/2 interventional study of Pegzilarginase and Pembrolizumab in Small-cell Lung Cancer, sponsored by Immedica Pharma AB. Terminated at 22 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.

Sponsored by Immedica Pharma AB · Phase 1/2, Interventional, and Treatment

Why this study was terminated
Study enrollment was halted early based on ongoing data monitoring; no efficacy analyses were performed
Updated Oct 28, 2026Now TerminatedResults posted+9 moreGo to Updates ↓
Phase
Phase 1/2
Study type
Interventional
Enrollment
42
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The main purpose of this Phase 1/2 study is to determine the safety and efficacy of pegzilarginase in combination with pembrolizumab in patients with ED-SCLC who have relapsed or progressive disease on or within 6 months of platinum-based chemotherapy.

Read the detailed description

Main purpose of this Phase 1/2 study is to determine the safety and efficacy of pegzilarginase in combination with pembrolizumab in patients with ED-SCLC who have relapsed or progressive disease on or within 6 months of platinum-based chemotherapy.

02

Conditions studied

  • Small-cell Lung Cancer
03

In context

Small Cell Lung Carcinoma

1,301 studies on the registry are indexed under Small Cell Lung Carcinoma; 367 are open to participants now.

This study's enrollment of 42 is below the median of 56 across 1,077 interventional studies indexed under Small Cell Lung Carcinoma.

Browse Small Cell Lung Carcinoma studies →

Lead sponsor

Immedica Pharma AB is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 28, 2026. See what changed

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  1. Patient is able and willing to provide written
  2. Be > 18 years of age on day of signing informed consent
  3. Have or cytologically confirmed SCLC that meets:

    1. Extensive disease per criteria of the International Association for the Study of Lung Cancer (IASLC)-American Joint Committee on Cancer (AJCC) TNM staging system
    2. Have not tolerated or have progressed or on or within 6 months of platinum-based chemotherapy
  4. Have a performance status of ≤ 1 on the Performance Scale
  5. Have based on 1.1
  6. Willing to undergo core needle or incisional to obtain fresh tumor tissue specimens
  7. Demonstrate adequate organ function as evidenced by laboratory testing with specimens collected within 10 days prior to day 1 of cycle 1
  8. Must have recovered from the effects of any prior systemic therapy, radiotherapy or surgery to Grade 1 or less
  9. If received major surgery or radiation therapy of > 30 Gy, recovered from the toxicity and/or complications from the intervention is required
  10. Female must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication
  11. Sexually active male or female must be surgically sterile , or must agree to use a physician-approved method of during the study through a minimum of 120 days after the last study drug administration.

Key Exclusion Criteria:

  1. Has received more than 2 platinum-based regimens against SCLC
  2. Has received pembrolizumab, or prior therapy with an , anti-PD-L1, anti-PD-L2, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody as part of any previous therapy, including trials
  3. Has participated in Merck MK-3475 (pembrolizumab) clinical trials
  4. Has received pegzilarginase as part of any previous therapy
  5. Is currently participating in a study of an agent or received the last dose of an investigational agent within 4 weeks prior to the first dose of treatment in this study (a shorter interval for kinase inhibitors or other short half-life drugs could be considered after approval from the Sponsor). Is currently participating in a study of an investigational device within 4 weeks of the first dose of treatment
  6. Has a diagnosis of an immunodeficiency, is receiving systemic therapy (except for physiological dose levels), or therapies
  7. Has had a prior monoclonal antibody (mAb) within 4 weeks prior to first dose or who has not recovered (i.e., ≤ Grade 1) from adverse reactions due to agents administered more than 4 weeks earlier
  8. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to first dose or who has not recovered (i.e., ≤ Grade 1 or at baseline) from treatment-emergent adverse reactions due to a previously administered agent
  9. If the patient has undergone major surgery, must have recovered adequately from the toxicity and/or complications prior to starting therapy
  10. Has received transfusion of blood products or administration of colony stimulating factors within 14 days prior to first study dose
  11. Has a known additional that is progressing or has required active treatment within the past 3 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer) that has undergone potentially curative therapy
  12. Has known central nervous system (CNS) . However, patients with previously treated may participate provided neurologic symptoms have stabilized, there is no evidence of new brain metastases or hemorrhage and they are not using steroids for brain metastases or for complications derived from their treatment for at least 7 days prior to the first dose of study treatment
  13. Has known carcinomatous meningitis
  14. Has an active disease requiring systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs) or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Patients with vitiligo or resolved childhood asthma/atopy are an exception to this rule. Patients that require intermittent use of bronchodilators or local steroid injections will not be excluded from the study. Patients with hypothyroidism stable on hormone replacement or Sjorgen's syndrome will not be excluded from the study. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc) is not considered a form of systemic treatment
  15. Has evidence of interstitial lung disease, history of non-infectious pneumonitis that required steroids, or current pneumonitis
  16. Has an active infection requiring systemic therapy
  17. Inadequately controlled hypertension (defined as systolic blood pressure ≥ 200 mmHg and/or diastolic blood pressure ≥ 120 mmHg) on more than one occasion in the month before planned day of infusion
  18. Currently taking 3 or more anti-hypertensive medications
  19. Prior history of hypertensive crisis or hypertensive encephalopathy
  20. History of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or cardiac or vascular surgery within 6 months prior to day 1 of study treatment
  21. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator
  22. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
  23. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment
  24. Has a known history of (HIV) (positive for HIV p24 antigen or HIV 1/2 antibodies)
  25. Has known active (e.g., HBsAg reactive) or (e.g., HCV RNA [qualitative] is detected)
  26. Has received a live-virus vaccination within 30 days prior to the planned first dose of study therapy
  27. Has a known history of active tuberculosis (Bacillus tuberculosis)
  28. Has a history of to PEG or any component of the pegzilarginase formulation
  29. Severe hypersensitivity (≥ Grade 3) to any of pegzilarginase or pembrolizumab
  30. Has had an allogenic tissue/solid organ transplant.
Terms in these criteria, in plain language(23)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    Pegzilarginase plus Pembrolizumab

    Phase 1 \& 2

    Drug: Pegzilarginase · Drug: Pembrolizumab

Interventions

06

What researchers measure

Primary outcomes

  1. Phase 1: Incidence of Treatment-realted Adverse Events as Assessed by CTCAE v4.0

    Number of participants experiencing treatment-related adverse events as assessed by CTCAE v4.0.

    Time frame: Estimated up to 6 months

Secondary outcomes

  1. Phase 2: Incidence of Treatment-related Adverse Events as Assessed by CTCAE v4.0

    Number of participants experiencing treatment-related adverse events as assessed by CTCAE v4.0.

    Time frame: From first treatment up to 24 months

07

Results

Posted Oct 28, 2026

Participant flow

Phase 1
Participant flow — Phase 1
MilestonePhase 2 - Pegzilarginase 0.27 mg/kg Plus Pembrolizumab 200 mgPhase 1 - Pegzilarginase 0.20 mg/kg + Pembrolizumab 200 mgPhase 1 - Pegzilarginase 0.27 mg/kg + Pembrolizumab 200 mgPhase 1 - Pegzilarginase 0.33 mg/kg + Pembrolizumab 200 mg
Started0394
Completed0000
Not completed0394
Phase 2
Participant flow — Phase 2
MilestonePhase 2 - Pegzilarginase 0.27 mg/kg Plus Pembrolizumab 200 mgPhase 1 - Pegzilarginase 0.20 mg/kg + Pembrolizumab 200 mgPhase 1 - Pegzilarginase 0.27 mg/kg + Pembrolizumab 200 mgPhase 1 - Pegzilarginase 0.33 mg/kg + Pembrolizumab 200 mg
Started26000
Completed0000
Not completed26000

Outcome measures

SecondaryPhase 2: Incidence of Treatment-related Adverse Events as Assessed by CTCAE v4.0

Number of participants experiencing treatment-related adverse events as assessed by CTCAE v4.0.

Time frame:
From first treatment up to 24 months
Reported as:
Count of participants · Participants
Phase 2: Incidence of Treatment-related Adverse Events as Assessed by CTCAE v4.0
ParticipantsPhase 2 - Pegzilarginase 0.27 mg/kg Plus Pembrolizumab 200 mg
Phase 2: Incidence of Treatment-related Adverse Events as Assessed by CTCAE v4.024
PrimaryPhase 1: Incidence of Treatment-realted Adverse Events as Assessed by CTCAE v4.0

Number of participants experiencing treatment-related adverse events as assessed by CTCAE v4.0.

Time frame:
Estimated up to 6 months
Reported as:
Count of participants · Participants
Phase 1: Incidence of Treatment-realted Adverse Events as Assessed by CTCAE v4.0
ParticipantsPhase 1 - Pegzilarginase 0.20 mg/kg + Pembrolizumab 200 mgPhase 1 - Pegzilarginase 0.27 mg/kg + Pembrolizumab 200 mgPhase 1 - Pegzilarginase 0.33 mg/kg + Pembrolizumab 200 mg
Phase 1: Incidence of Treatment-realted Adverse Events as Assessed by CTCAE v4.0284

Adverse events

Collected over From the first dose of study drug continuing through the last study follow-up visit (range of treatment cycles during the study was 1-30 with 4 weeks/cycle). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Phase 2 - Pegzilarginase 0.27 mg/kg Plus Pembrolizumab 200 mg4/26 (15.4%)16/26 (61.5%)26/26 (100%)
Phase 1 - Pegzilarginase 0.20 mg/kg + Pembrolizumab 200 mg0/3 (0%)1/3 (33.3%)3/3 (100%)
Phase 1 - Pegzilarginase 0.27 mg/kg + Pembrolizumab 200 mg0/9 (0%)2/9 (22.2%)9/9 (100%)
Phase 1 - Pegzilarginase 0.33 mg/kg + Pembrolizumab 200 mg0/4 (0%)2/4 (50%)4/4 (100%)
Most frequent serious events
Showing 10 of 20
Most frequent serious events
EventPhase 2 - Pegzilarginase 0.27 mg/kg Plus Pembrolizumab 200 mgPhase 1 - Pegzilarginase 0.20 mg/kg + Pembrolizumab 200 mgPhase 1 - Pegzilarginase 0.27 mg/kg + Pembrolizumab 200 mgPhase 1 - Pegzilarginase 0.33 mg/kg + Pembrolizumab 200 mg
HyponatraemiaMetabolism and nutrition disorders1/261/30/90/4
NauseaGastrointestinal disorders1/260/30/91/4
VomitingGastrointestinal disorders1/260/30/91/4
DehydrationMetabolism and nutrition disorders1/260/30/91/4
HypophosphataemiaMetabolism and nutrition disorders0/260/30/91/4
Abdominal painGastrointestinal disorders1/260/31/90/4
Confusional statePsychiatric disorders0/260/31/90/4
AstheniaGeneral disorders2/260/30/90/4
Respiratory failureRespiratory, thoracic and mediastinal disorders2/260/30/90/4
Cardio-respiratory arrestCardiac disorders1/260/30/90/4
Most frequent other events
Showing 10 of 136
Most frequent other events
EventPhase 2 - Pegzilarginase 0.27 mg/kg Plus Pembrolizumab 200 mgPhase 1 - Pegzilarginase 0.20 mg/kg + Pembrolizumab 200 mgPhase 1 - Pegzilarginase 0.27 mg/kg + Pembrolizumab 200 mgPhase 1 - Pegzilarginase 0.33 mg/kg + Pembrolizumab 200 mg
VomitingGastrointestinal disorders14/263/34/94/4
Decreased appetiteMetabolism and nutrition disorders11/261/33/94/4
HeadacheNervous system disorders1/263/33/92/4
NauseaGastrointestinal disorders13/262/35/93/4
FatigueGeneral disorders16/262/35/93/4
HyponatraemiaMetabolism and nutrition disorders3/262/34/93/4
DizzinessNervous system disorders2/260/35/93/4
DepressionPsychiatric disorders1/260/30/93/4
DiarrhoeaGastrointestinal disorders8/262/31/90/4
Oedema peripheralGeneral disorders0/262/32/91/4

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Phase 2 - Pegzilarginase 0.27 mg/kg + Pembrolizumab 200 mgPhase 1 - Pegzilarginase 0.20 mg/kg + Pembrolizumab 200 mgPhase 1 - Pegzilarginase 0.27 mg/kg + Pembrolizumab 200 mgPhase 1 - Pegzilarginase 0.33 mg/kg + Pembrolizumab 200 mgTotal
Mean63.0 ± 8.063.7 ± 2.566.4 ± 8.461.3 ± 7.363.6 ± 7.7
Sex: Female, Male
Sex: Female, Male(Participants)Phase 2 - Pegzilarginase 0.27 mg/kg + Pembrolizumab 200 mgPhase 1 - Pegzilarginase 0.20 mg/kg + Pembrolizumab 200 mgPhase 1 - Pegzilarginase 0.27 mg/kg + Pembrolizumab 200 mgPhase 1 - Pegzilarginase 0.33 mg/kg + Pembrolizumab 200 mgTotal
Female1625225
Male1014217
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Phase 2 - Pegzilarginase 0.27 mg/kg + Pembrolizumab 200 mgPhase 1 - Pegzilarginase 0.20 mg/kg + Pembrolizumab 200 mgPhase 1 - Pegzilarginase 0.27 mg/kg + Pembrolizumab 200 mgPhase 1 - Pegzilarginase 0.33 mg/kg + Pembrolizumab 200 mgTotal
American Indian or Alaska Native00101
Asian00011
Native Hawaiian or Other Pacific Islander00000
Black or African American20002
White2438338
More than one race00000
Unknown or Not Reported00000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Phase 2 - Pegzilarginase 0.27 mg/kg + Pembrolizumab 200 mgPhase 1 - Pegzilarginase 0.20 mg/kg + Pembrolizumab 200 mgPhase 1 - Pegzilarginase 0.27 mg/kg + Pembrolizumab 200 mgPhase 1 - Pegzilarginase 0.33 mg/kg + Pembrolizumab 200 mgTotal
Hispanic or Latino00000
Not Hispanic or Latino2639442
Unknown or Not Reported00000
ECOG Performance Status
ECOG Performance Status(Participants)Phase 2 - Pegzilarginase 0.27 mg/kg + Pembrolizumab 200 mgPhase 1 - Pegzilarginase 0.20 mg/kg + Pembrolizumab 200 mgPhase 1 - Pegzilarginase 0.27 mg/kg + Pembrolizumab 200 mgPhase 1 - Pegzilarginase 0.33 mg/kg + Pembrolizumab 200 mgTotal
0902112
11737330
200000
08

Study locations

22 sites
  • University of Alabama, Mitchell Cancer Institute
    Mobile, Alabama 36604, United States
  • University of Colorado
    Aurora, Colorado 80045, United States
  • Rocky Mountain Cancer Centers
    Denver, Colorado 80218, United States
  • Mid Florida Hematology and Oncology Centers
    Orange City, Florida 32763, United States
  • Woodlands Medical Specialists, PA
    Pensacola, Florida 32503, United States
  • Moffitt Cancer Center
    Tampa, Florida 33612, United States
  • Emory University
    Atlanta, Georgia 30307, United States
  • University of Michigan
    Ann Arbor, Michigan 48109, United States
  • Karmanos Cancer Institute
    Detroit, Michigan 48201, United States
  • Washington University
    St Louis, Missouri 63110, United States
  • Nebraska Cancer Specialists
    Omaha, Nebraska 68130, United States
  • The Valley Hospital, Luckow Pavilion
    Paramus, New Jersey 07652, United States
  • Oncology Hematology Care Inc.
    Cincinnati, Ohio 45242, United States
  • Providence Cancer Center
    Portland, Oregon 97213, United States
  • UPMC Cancer Center
    Pittsburgh, Pennsylvania 15232, United States
  • Charleston Hematology Oncology Associates
    Charleston, South Carolina 29414, United States
  • West Clinic
    Germantown, Tennessee 38138, United States
  • Sarah Cannon Research Institute
    Nashville, Tennessee 37203, United States
  • Texas Oncology-Memorial City
    Houston, Texas 77024, United States
  • Texas Oncology-Tyler
    Tyler, Texas 75702, United States
  • Oncology & Hematology Associates of SW Virginia
    Blacksburg, Virginia 24060, United States
  • Fundacion De Investigacion, Hematology/Oncology
    San Juan, Puerto Rico 00927, Puerto Rico
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

1 registry update since Sep 25, 2026
Status
Completed→Terminated Study enrollment was halted early based on ongoing data monitoring; no efficacy analyses were performed
changed Oct 28, 2026
Results
Results posted
posted Oct 28, 2026
Sites
2 sites added, 2 sites removed
Show 2 added (1 United States, 1 Puerto Rico)
  • Washington University · St Louis, United States
  • Fundacion De Investigacion, Hematology/Oncology · San Juan, Puerto Rico
Show 2 removed
  • Washington University · Saint Louis, United States
  • Fundacion De Investigacion, Hematology/Oncology · San Juan, Puerto Rico
Oct 28, 2026
Primary completion
Jan 1, 2021→Jun 11, 2020
Oct 28, 2026
Study completion
Jan 1, 2021→Jun 11, 2020
Oct 28, 2026
Enrollment
68→42
Oct 28, 2026
Eligibility
1 criterion edited, 12 added
What changed in the criteria
  • AddedMust have recovered from the effects of any prior systemic therapy, radiotherapy or surgery to Grade 1 or less
  • AddedIf received major surgery or radiation therapy of > 30 Gy, recovered from the toxicity and/or complications from the intervention is required
  • AddedHas had a prior monoclonal antibody (mAb) within 4 weeks prior to first dose or who has not recovered (i.e., ≤ Grade 1) from adverse reactions due to agents administered more than 4 weeks earlier
  • AddedHas had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to first dose or who has not recovered (i.e., ≤ Grade 1 or at baseline) from treatment-emergent adverse reactions due to a previously administered agent
  • AddedIf the patient has undergone major surgery, must have recovered adequately from the toxicity and/or complications prior to starting therapy
  • AddedHas received transfusion of blood products or administration of colony stimulating factors within 14 days prior to first study dose
  • EditedHas known central nervous system (CNS) metastases. However, patients with previously treated brain metastases may participate provided neurologic symptoms have stabilized, there is no evidence of new brain metastases or hemorrhage and they are not using steroids for brain metastases or for complications derived from their treatment for at least 7 days prior to the first dose of trialstudy treatment
  • AddedHas an active infection requiring systemic therapy
  • AddedHas a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator
  • AddedHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
  • AddedHas received a live-virus vaccination within 30 days prior to the planned first dose of study therapy
  • AddedHas a history of hypersensitivity to PEG or any component of the pegzilarginase formulation
  • AddedSevere hypersensitivity (≥ Grade 3) to any excipient of pegzilarginase or pembrolizumab
Oct 28, 2026
Primary outcomes
1 edited, 1 removed
What changed in the outcomes
  • Edited1. Phase 1: Incidence of treatmentTreatment-related adverse eventsrealted Adverse Events as assessedAssessed by CTCAE v4.0Time frame: Estimated up to 6 months
  • RemovedPhase 2: Efficacy determined by Objective Response Rate (ORR:CR+PR) per RECIST 1.1.Time frame: Estimated up to 6 months
Oct 28, 2026
Documents
Secondary outcomes
1 edited, 6 removed
What changed in the outcomes
  • EditedPhase 2: Incidence of treatmentTreatment-related adverse eventsAdverse Events as assessedAssessed by CTCAE v4.0Time frame: From first treatment up to 24 months
  • RemovedObjective Response RateTime frame: At 9, 18, and 27 weeks after first dose and every 12 weeks thereafter up to 24 months
  • RemovedClinical Benefit RateTime frame: At 18 and 27 weeks after first dose and every 12 weeks thereafter up to 24 months
  • RemovedTime to ResponseTime frame: At 9, 18, and 27 weeks after first dose and every 12 weeks thereafter up to 24 months
  • RemovedDuration of ResponseTime frame: At 18 and 27 weeks after first dose and every 12 weeks thereafter up to 24 months
  • RemovedProgression free survivalTime frame: From first treatment up to 24 months
  • RemovedOverall SurvivalTime frame: From first treatment up to 24 months
Oct 28, 2026
Sponsor
Aeglea Biotherapeutics→Immedica Pharma AB; Collaborators added: Aeglea Biotherapeutics
Oct 28, 2026
Show all 1 update
  1. Oct 28, 2026
    Completed→Terminated
    Why stopped Study enrollment was halted early based on ongoing data monitoring; no efficacy analyses were performed
    Results posted
    2 sites added, 2 sites removed
    Show 2 added (1 United States, 1 Puerto Rico)
    • Washington University · St Louis, United States
    • Fundacion De Investigacion, Hematology/Oncology · San Juan, Puerto Rico
    Show 2 removed
    • Washington University · Saint Louis, United States
    • Fundacion De Investigacion, Hematology/Oncology · San Juan, Puerto Rico
    Primary completion Jan 1, 2021→Jun 11, 2020
    Study completion Jan 1, 2021→Jun 11, 2020
    Enrollment 68→42
    Eligibility 1 criterion edited, 12 added
    What changed in the criteria
    • AddedMust have recovered from the effects of any prior systemic therapy, radiotherapy or surgery to Grade 1 or less
    • AddedIf received major surgery or radiation therapy of > 30 Gy, recovered from the toxicity and/or complications from the intervention is required
    • AddedHas had a prior monoclonal antibody (mAb) within 4 weeks prior to first dose or who has not recovered (i.e., ≤ Grade 1) from adverse reactions due to agents administered more than 4 weeks earlier
    • AddedHas had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to first dose or who has not recovered (i.e., ≤ Grade 1 or at baseline) from treatment-emergent adverse reactions due to a previously administered agent
    • AddedIf the patient has undergone major surgery, must have recovered adequately from the toxicity and/or complications prior to starting therapy
    • AddedHas received transfusion of blood products or administration of colony stimulating factors within 14 days prior to first study dose
    • EditedHas known central nervous system (CNS) metastases. However, patients with previously treated brain metastases may participate provided neurologic symptoms have stabilized, there is no evidence of new brain metastases or hemorrhage and they are not using steroids for brain metastases or for complications derived from their treatment for at least 7 days prior to the first dose of trialstudy treatment
    • AddedHas an active infection requiring systemic therapy
    • AddedHas a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator
    • AddedHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
    • AddedHas received a live-virus vaccination within 30 days prior to the planned first dose of study therapy
    • AddedHas a history of hypersensitivity to PEG or any component of the pegzilarginase formulation
    • AddedSevere hypersensitivity (≥ Grade 3) to any excipient of pegzilarginase or pembrolizumab
    Primary outcomes 1 edited, 1 removed
    What changed in the outcomes
    • Edited1. Phase 1: Incidence of treatmentTreatment-related adverse eventsrealted Adverse Events as assessedAssessed by CTCAE v4.0Time frame: Estimated up to 6 months
    • RemovedPhase 2: Efficacy determined by Objective Response Rate (ORR:CR+PR) per RECIST 1.1.Time frame: Estimated up to 6 months
    Secondary outcomes 1 edited, 6 removed
    What changed in the outcomes
    • EditedPhase 2: Incidence of treatmentTreatment-related adverse eventsAdverse Events as assessedAssessed by CTCAE v4.0Time frame: From first treatment up to 24 months
    • RemovedObjective Response RateTime frame: At 9, 18, and 27 weeks after first dose and every 12 weeks thereafter up to 24 months
    • RemovedClinical Benefit RateTime frame: At 18 and 27 weeks after first dose and every 12 weeks thereafter up to 24 months
    • RemovedTime to ResponseTime frame: At 9, 18, and 27 weeks after first dose and every 12 weeks thereafter up to 24 months
    • RemovedDuration of ResponseTime frame: At 18 and 27 weeks after first dose and every 12 weeks thereafter up to 24 months
    • RemovedProgression free survivalTime frame: From first treatment up to 24 months
    • RemovedOverall SurvivalTime frame: From first treatment up to 24 months
    Sponsor Aeglea Biotherapeutics→Immedica Pharma AB; Collaborators added: Aeglea Biotherapeutics
    + 5 other changes: index terms, identifiers, verification date, description and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT03371979
Lead sponsor
Immedica Pharma AB
Collaborators
Merck Sharp & Dohme LLC, Aeglea Biotherapeutics
Responsible party
Sponsor
First posted
Dec 13, 2017
Start date
Dec 21, 2017
Primary completion
Jun 11, 2020
Completion
Jun 11, 2020
Results posted
Oct 28, 2026
Last update
Oct 28, 2026

Study contacts

Mattias Rudebeck, PhD MSc BMedSc
study director · Immedica Pharma AB

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Pegzilarginase

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