ClinicalTrials.gg
CompletedNCT03304639Updated Aug 25, 2026Results posted

Testing the Addition of Radiation Therapy to Immunotherapy for Merkel Cell Carcinoma

A Phase 2 interventional study of Pembrolizumab and Stereotactic Body Radiation Therapy in Advanced Merkel Cell Carcinoma, Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8 and Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8, sponsored by National Cancer Institute (NCI). Completed at 254 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.

Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment

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Phase
Phase 2
Study type
Interventional
Enrollment
9
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 11 studies in Carcinoma, Merkel Cell by National Cancer Institute (NCI) — 1 open to participants now, 5 under way, 1 of them phase 3. Carcinoma, Merkel Cell · National Cancer Institute (NCI).

Enrollment
10th of 11
9 · median 37
Started
2018
with 1 other
Phase 2
7 of 11
none open now
Registered
7th of 11
by date

Among the 11 studies in Carcinoma, Merkel Cell by National Cancer Institute (NCI), this one is the 10th largest by enrollment, is one of 2 that started in 2018, is one of 7 in phase 2, and was the 7th registered.

Carcinoma, Merkel Cell

150 studies on the registry are indexed under Carcinoma, Merkel Cell; 40 are open to participants now.

Browse Carcinoma, Merkel Cell studies →

Open to participants now

1 of the 11 studies in Carcinoma, Merkel Cell by National Cancer Institute (NCI) is open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

Where they have run

Who these studies take

Of the 34 Carcinoma, Merkel Cell studies recruiting now, 27 (79%) set no upper age limit and none (0%) stop at 75 or younger; 5 take children under 18; 1 takes healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 11 studies in Carcinoma, Merkel Cell by National Cancer Institute (NCI), or all of them as a file.
02

Study summary

This randomized phase II trial studies how well pembrolizumab with or without stereotactic body radiation therapy works in treating patients with Merkel cell cancer that has spread to other places in the body (advanced). 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. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving pembrolizumab with stereotactic body radiation therapy may work better in treating patients with Merkel cell cancer.

Read the detailed description

PRIMARY OBJECTIVE:

I. To describe the progression-free survival (PFS) of stereotactic body radiation therapy (SBRT) + pembrolizumab (MK-3475) compared to pembrolizumab (MK-3475) alone in advanced/metastatic Merkel cell carcinoma (MCC) patients.

SECONDARY OBJECTIVES:

I. To describe the PFS of SBRT + MK-3475 compared to pembrolizumab (MK-3475) alone across Response Evaluation Criteria in Solid Tumors (RECIST) measurable (including both radiated and non-radiated) cancer deposits.

II. To describe the overall response rate of SBRT + pembrolizumab (MK-3475) compared to pembrolizumab(MK-3475) alone in both radiated and in non-radiated deposit(s).

III. To determine the PFS at 6 months of SBRT + pembrolizumab (MK-3475) compared to pembrolizumab (MK-3475) alone across all cancerous deposits by RECIST.

IV. To determine the rate of grade > 3-4 adverse events, by organ system, by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.

V. To determine the local control of SBRT treated tumors. VI. To calculate delivered radiation dose using cone-beam computed tomography (CT) images collected on the radiation treatment table in the final treatment position.

CORRELATIVE SCIENCE OBJECTIVES:

I. To test the utility of CT-based radiomics to predict radiation-induced pneumonitis and true delivered dose of SBRT based on cone beam collected imaging and diagnostic scans.

II. Biobanking for future correlative science projects.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

GROUP II: Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo SBRT for 3 doses during cycle 1.

After completion of study treatment, patients are followed up every 6 months for up to 5 years.

03

Conditions studied

  • Advanced Merkel Cell Carcinoma
  • Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8
  • Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8
  • Metastatic Merkel Cell Carcinoma
  • Pathologic Stage III Cutaneous Merkel Cell Carcinoma AJCC v8
  • Pathologic Stage IIIA Cutaneous Merkel Cell Carcinoma AJCC v8
  • Pathologic Stage IIIB Cutaneous Merkel Cell Carcinoma AJCC v8
  • Pathologic Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8
04

Who can participate

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

Eligibility criteria

Inclusion Criteria:

  • Patients must have pathologically (histologically or cytologically) proven diagnosis of MCC by local pathology review
  • Have based on 1.1 including at least two cancerous deposits; at least one deposit must be RECIST measurable while at least one deposit must meet criteria for SBRT; non-radiated tumor will be identified prior to randomization on the protocol
  • Patients must have advanced or MCC defined as evidence of distant metastasis(es) on imaging

    • Patients with locoregionally confined disease are not eligible
  • No prior immunotherapy for advanced/metastatic MCC
  • Patients with known or suspected central nervous system (CNS) metastases, untreated , or with the CNS as the only site of disease are excluded; however, subjects with controlled brain metastases will be allowed to enroll; controlled brain metastases are defined as no radiographic progression for at least 4 weeks following radiation and/or surgical treatment (or 4 weeks of observation if no intervention is clinically indicated), and off of for at least 2 weeks, and no new or progressive neurological signs and symptoms
  • Patients having received palliative radiotherapy for extracranial metastasis(es) are eligible as long as there are 2 cancerous deposits that have not received prior radiation therapy (RT) and they meet the following criteria

    • No prior radiation therapy (> 5 Gy) to the metastasis intended to be treated with SBRT
  • No history of the following:

    • Autoimmunity requiring systemic within 2 years
    • Patients known to be (HIV) positive are eligible if they meet the following:

      • >= 350 mm\^3
      • Serum HIV viral load of \< 25,000 IU/ml
  • No other active that the investigator determines would interfere with the treatment and safety analysis
  • Not pregnant and not nursing, because this study involves an agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown; therefore, for women of only, a negative (if your test schedule specifically indicates a urine or serum pregnancy test, add that information at this point) pregnancy test done =\< 28 days prior to registration is required
  • (ECOG) performance status 0-2
  • (ANC) >= 1,500/mm\^3
  • count >= 100,000/mm\^3
  • >= 9.0 g/dl
  • Total =\< 2.0 mg/dl
  • (AST)/alanine aminotransferase (ALT) =\< 3.0 x (ULN)
  • Systolic blood pressure (BP) =\< 150 mg HG
  • Diastolic BP =\< 90 mg HG
  • Albumin > 3 mg/dl
  • Blood urea nitrogen (BUN) =\< 30 mg/dl
  • Creatinine =\< 1.7 mg/dl
  • The following imaging workup to document metastases within 45 days prior to study registration are required: CT scans of the chest, abdomen and pelvis with radionuclide bone scan OR whole body (at least skull base to midthigh) positron emission tomography (PET)/CT
Terms in these criteria, in plain language(18)

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.

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.

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.

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.

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.

CD4 count

The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.

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.

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.

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.

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.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Active comparator
    Group I (pembrolizumab)

    Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

    Biological: Pembrolizumab

  • Experimental
    Group II (pembrolizumab, SBRT)

    Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo SBRT for 3 doses during cycle 1.

    Biological: Pembrolizumab · Radiation: Stereotactic Body Radiation Therapy

Interventions

  • BiologicalPembrolizumab

    Given IV

    Also known as: BCD-201, GME 751, GME751, Keytruda, Lambrolizumab, MK 3475, MK-3475, MK3475, Pembrolizumab Biosimilar BCD-201, Pembrolizumab Biosimilar GME751, Pembrolizumab Biosimilar QL2107, Pembrolizumab Biosimilar RPH-075, Pembrolizumab Biosimilar SB27, QL2107, RPH 075, RPH-075, RPH075, SB 27, SB-27, SB27, SCH 900475, SCH-900475, SCH900475

  • RadiationStereotactic Body Radiation Therapy

    Undergo SBRT

    Also known as: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

06

What researchers measure

Primary outcomes

  1. Progression-free Survival (PFS)

    Will compare PFS in non-radiated lesion(s) of patients receiving either (a) stereotactic body radiation therapy (SBRT) + pembrolizumab compared to (b) pembrolizumab alone in patients with advanced Merkel cell carcinoma. Kaplan- Meier curves will be constructed and median PFS times will be calculated for each arm. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

    Time frame: From randomization to either disease progression or death (without progression), assessed up to 3 years

Secondary outcomes

  1. PFS Among All Response Evaluation Criteria in Solid Tumors Lesions

    Same as the primary endpoint, but includes both irradiated and non-radiated lesions. It is a time to event endpoint and will be evaluated using the Kaplan- Meier method. Median PFS times will be calculated for each arm and a cox proportional hazards model will be constructed to determine if there is a PFS benefit for patients receiving SBRT + pembrolizumab compared to pembrolizumab alone.

    Time frame: From randomization to either evidence of disease progression or death (without evidence of progression), assessed up to 3 years

  2. Overall Response Rate

    Defined as partial response (PR) on 2 consecutive evaluations. Response rates will be calculated and compared across treatment arms utilizing a chi-square test.

    Time frame: Up to 3 years

  3. Progression-free Survival

    The rates of success will be calculated and compared across treatment arms utilizing a chi-square test.

    Time frame: At 6 months

  4. Number of Participants With Grade 3+ Adverse Events

    Graded according to National Cancer Institute's Common Terminology Criteria for Adverse Events, version 5.0. Maximum grade adverse events will be summarized by treatment arm in a tabular setting.

    Time frame: Up to 3 months

  5. PFS for Lesions Chosen for Radiation Prior to Randomization

    The protocol irradiated tumors are considered to be controlled if they have no evidence of progression. No evidence of progression is defined as complete response, PR, or stable disease. Local control of the protocol-irradiated tumor will be described using the Kaplan-Meier technique.

    Time frame: Up to 3 years

  6. Delivered Radiation Dose Using Cone-beam Computed Tomography (CT) Images

    Radiation doses will be summarized descriptively and compared to the planned dose.

    Time frame: Up to 3 years

07

Results

Posted Feb 8, 2024

Participant flow

Participant flow — Overall Study
MilestoneGroup I (Pembrolizumab)Group II (Pembrolizumab, SBRT)
Started45
Completed45
Not completed00

Outcome measures

PrimaryProgression-free Survival (PFS)

Will compare PFS in non-radiated lesion(s) of patients receiving either (a) stereotactic body radiation therapy (SBRT) + pembrolizumab compared to (b) pembrolizumab alone in patients with advanced Merkel cell carcinoma. Kaplan- Meier curves will be constructed and median PFS times will be calculated for each arm. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Time frame:
From randomization to either disease progression or death (without progression), assessed up to 3 years
Reported as:
Median · months
Progression-free Survival (PFS)
monthsGroup I (Pembrolizumab)Group II (Pembrolizumab, SBRT)
Progression-free Survival (PFS)7.5 (1.6 to NA)5.5 (3.7 to NA)
SecondaryPFS Among All Response Evaluation Criteria in Solid Tumors Lesions

Same as the primary endpoint, but includes both irradiated and non-radiated lesions. It is a time to event endpoint and will be evaluated using the Kaplan- Meier method. Median PFS times will be calculated for each arm and a cox proportional hazards model will be constructed to determine if there is a PFS benefit for patients receiving SBRT + pembrolizumab compared to pembrolizumab alone.

Time frame:
From randomization to either evidence of disease progression or death (without evidence of progression), assessed up to 3 years
Reported as:
Median · months
PFS Among All Response Evaluation Criteria in Solid Tumors Lesions
monthsGroup I (Pembrolizumab)Group II (Pembrolizumab, SBRT)
PFS Among All Response Evaluation Criteria in Solid Tumors Lesions7.5 (1.6 to NA)NA (5.5 to NA)
SecondaryOverall Response Rate

Defined as partial response (PR) on 2 consecutive evaluations. Response rates will be calculated and compared across treatment arms utilizing a chi-square test.

Time frame:
Up to 3 years
Reported as:
Count of participants · Participants
Overall Response Rate
ParticipantsGroup I (Pembrolizumab)Group II (Pembrolizumab, SBRT)
Overall Response Rate12
SecondaryProgression-free Survival

The rates of success will be calculated and compared across treatment arms utilizing a chi-square test.

Time frame:
At 6 months
Reported as:
Count of participants · Participants
Progression-free Survival
ParticipantsGroup I (Pembrolizumab)Group II (Pembrolizumab, SBRT)
Progression-free Survival12
SecondaryNumber of Participants With Grade 3+ Adverse Events

Graded according to National Cancer Institute's Common Terminology Criteria for Adverse Events, version 5.0. Maximum grade adverse events will be summarized by treatment arm in a tabular setting.

Time frame:
Up to 3 months
Reported as:
Count of participants · Participants
Number of Participants With Grade 3+ Adverse Events
ParticipantsGroup I (Pembrolizumab)Group II (Pembrolizumab, SBRT)
Number of Participants With Grade 3+ Adverse Events34
SecondaryPFS for Lesions Chosen for Radiation Prior to Randomization

The protocol irradiated tumors are considered to be controlled if they have no evidence of progression. No evidence of progression is defined as complete response, PR, or stable disease. Local control of the protocol-irradiated tumor will be described using the Kaplan-Meier technique.

Time frame:
Up to 3 years
Reported as:
Count of participants · Participants
PFS for Lesions Chosen for Radiation Prior to Randomization
ParticipantsGroup I (Pembrolizumab)Group II (Pembrolizumab, SBRT)
PFS for Lesions Chosen for Radiation Prior to Randomization—0
SecondaryDelivered Radiation Dose Using Cone-beam Computed Tomography (CT) Images

Radiation doses will be summarized descriptively and compared to the planned dose.

Time frame:
Up to 3 years
Reported as:
Median · cGY
Delivered Radiation Dose Using Cone-beam Computed Tomography (CT) Images
cGYGroup I (Pembrolizumab)Group II (Pembrolizumab, SBRT)
Planned Dose Cycle 1—24 (8 to 24)
Actual Dose Cycle 1—24 (8 to 24)
Planned Dose Cycle 2—16 (8 to 24)
Actual Dose Cycle 2—16 (8 to 24)

Adverse events

Collected over Up to 5 years. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group I (Pembrolizumab)0/4 (0%)0/4 (0%)4/4 (100%)
Group II (Pembrolizumab, SBRT)0/5 (0%)0/5 (0%)5/5 (100%)
Most frequent other events
Showing 10 of 61
Most frequent other events
EventGroup I (Pembrolizumab)Group II (Pembrolizumab, SBRT)
DiarrheaGastrointestinal disorders1/44/5
PainGeneral disorders and administration site conditions0/43/5
PruritusSkin and subcutaneous tissue disorders0/43/5
Creatinine increasedInvestigations2/40/5
AnorexiaMetabolism and nutrition disorders2/42/5
Peripheral sensory neuropathyNervous system disorders2/42/5
InsomniaPsychiatric disorders2/41/5
NauseaGastrointestinal disorders1/42/5
Edema limbsGeneral disorders and administration site conditions1/42/5
FatigueGeneral disorders and administration site conditions1/42/5

Baseline characteristics

Age, Continuous
Age, Continuous(years)Group I (Pembrolizumab)Group II (Pembrolizumab, SBRT)Total
Mean76.0 ± 9.769.0 ± 9.272.1 ± 9.5
Sex: Female, Male
Sex: Female, Male(Participants)Group I (Pembrolizumab)Group II (Pembrolizumab, SBRT)Total
Female011
Male448
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Group I (Pembrolizumab)Group II (Pembrolizumab, SBRT)Total
Hispanic or Latino000
Not Hispanic or Latino459
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Group I (Pembrolizumab)Group II (Pembrolizumab, SBRT)Total
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American000
White459
More than one race000
Unknown or Not Reported000
08

Study locations

254 sites
  • Anchorage Associates in Radiation Medicine
    Anchorage, Alaska 98508, United States
  • Alaska Breast Care and Surgery LLC
    Anchorage, Alaska 99508, United States
  • Alaska Oncology and Hematology LLC
    Anchorage, Alaska 99508, United States
  • Alaska Women's Cancer Care
    Anchorage, Alaska 99508, United States
  • Anchorage Oncology Centre
    Anchorage, Alaska 99508, United States
  • Katmai Oncology Group
    Anchorage, Alaska 99508, United States
  • Providence Alaska Medical Center
    Anchorage, Alaska 99508, United States
  • Banner University Medical Center - Tucson
    Tucson, Arizona 85719, United States
  • University of Arizona Cancer Center-North Campus
    Tucson, Arizona 85719, United States
  • Mercy Hospital Fort Smith
    Fort Smith, Arkansas 72903, United States
  • CHI Saint Vincent Cancer Center Hot Springs
    Hot Springs, Arkansas 71913, United States
  • PCR Oncology
    Arroyo Grande, California 93420, United States
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center
    Burbank, California 91505, United States
  • Penrose-Saint Francis Healthcare
    Colorado Springs, Colorado 80907, United States
  • Rocky Mountain Cancer Centers-Penrose
    Colorado Springs, Colorado 80907, United States
  • AdventHealth Porter
    Denver, Colorado 80210, United States
  • Saint Anthony Hospital
    Lakewood, Colorado 80228, United States
  • AdventHealth Littleton
    Littleton, Colorado 80122, United States
  • Longmont United Hospital
    Longmont, Colorado 80501, United States
  • AdventHealth Parker
    Parker, Colorado 80138, United States
  • Saint Mary Corwin Medical Center
    Pueblo, Colorado 81004, United States
  • Rocky Mountain Cancer Centers-Thornton
    Thornton, Colorado 80260, United States
  • Smilow Cancer Center/Yale-New Haven Hospital
    New Haven, Connecticut 06510, United States
  • Yale University
    New Haven, Connecticut 06520, United States
  • Mount Sinai Comprehensive Cancer Center at Aventura
    Aventura, Florida 33180, United States
  • Holy Cross Hospital
    Fort Lauderdale, Florida 33308, United States
  • Mount Sinai Medical Center
    Miami Beach, Florida 33140, United States
  • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
    Savannah, Georgia 31405, United States
  • Saint Alphonsus Cancer Care Center-Boise
    Boise, Idaho 83706, United States
  • Saint Luke's Cancer Institute - Boise
    Boise, Idaho 83712, United States
  • Saint Alphonsus Cancer Care Center-Caldwell
    Caldwell, Idaho 83605, United States
  • Kootenai Health - Coeur d'Alene
    Coeur d'Alene, Idaho 83814, United States
  • Saint Luke's Cancer Institute - Fruitland
    Fruitland, Idaho 83619, United States
  • Idaho Urologic Institute-Meridian
    Meridian, Idaho 83642, United States
  • Saint Luke's Cancer Institute - Meridian
    Meridian, Idaho 83642, United States
  • Saint Alphonsus Cancer Care Center-Nampa
    Nampa, Idaho 83687, United States
  • Saint Luke's Cancer Institute - Nampa
    Nampa, Idaho 83687, United States
  • Kootenai Clinic Cancer Services - Post Falls
    Post Falls, Idaho 83854, United States
  • Kootenai Clinic Cancer Services - Sandpoint
    Sandpoint, Idaho 83864, United States
  • Saint Luke's Cancer Institute - Twin Falls
    Twin Falls, Idaho 83301, United States
  • Rush-Copley Medical Center
    Aurora, Illinois 60504, United States
  • Northwestern University
    Chicago, Illinois 60611, United States
  • Rush MD Anderson Cancer Center
    Chicago, Illinois 60612, United States
  • University of Chicago Comprehensive Cancer Center
    Chicago, Illinois 60637, United States
  • Carle at The Riverfront
    Danville, Illinois 61832, United States
  • Carle Physician Group-Effingham
    Effingham, Illinois 62401, United States
  • Northwestern Medicine Lake Forest Hospital
    Lake Forest, Illinois 60045, United States
  • Carle Physician Group-Mattoon/Charleston
    Mattoon, Illinois 61938, United States
  • SSM Health Good Samaritan
    Mount Vernon, Illinois 62864, United States
  • UC Comprehensive Cancer Center at Silver Cross
    New Lenox, Illinois 60451, United States
  • University of Chicago Medicine-Orland Park
    Orland Park, Illinois 60462, United States
  • Carle Cancer Center
    Urbana, Illinois 61801, United States
  • The Carle Foundation Hospital
    Urbana, Illinois 61801, United States
  • Rush-Copley Healthcare Center
    Yorkville, Illinois 60560, United States
  • Indiana University/Melvin and Bren Simon Cancer Center
    Indianapolis, Indiana 46202, United States
  • Sidney and Lois Eskenazi Hospital
    Indianapolis, Indiana 46202, United States
  • Mercy Cancer Center-West Lakes
    Clive, Iowa 50325, United States
  • UI Health Care Mission Cancer and Blood - West Des Moines Clinic
    Clive, Iowa 50325, United States
  • Greater Regional Medical Center
    Creston, Iowa 50801, United States
  • Iowa Methodist Medical Center
    Des Moines, Iowa 50309, United States
  • UI Health Care Mission Cancer and Blood - Des Moines Clinic
    Des Moines, Iowa 50309, United States
  • Broadlawns Medical Center
    Des Moines, Iowa 50314, United States
  • Mercy Medical Center - Des Moines
    Des Moines, Iowa 50314, United States
  • UI Health Care Mission Cancer and Blood - Laurel Clinic
    Des Moines, Iowa 50314, United States
  • Iowa Lutheran Hospital
    Des Moines, Iowa 50316, United States
  • Methodist West Hospital
    West Des Moines, Iowa 50266-7700, United States
  • Mercy Medical Center-West Lakes
    West Des Moines, Iowa 50266, United States
  • Central Care Cancer Center - Garden City
    Garden City, Kansas 67846, United States
  • Central Care Cancer Center - Great Bend
    Great Bend, Kansas 67530, United States
  • University of Kansas Cancer Center
    Kansas City, Kansas 66160, United States
  • Lawrence Memorial Hospital
    Lawrence, Kansas 66044, United States
  • Kansas Institute of Medicine Cancer and Blood Center
    Lenexa, Kansas 66219, United States
  • Minimally Invasive Surgery Hospital
    Lenexa, Kansas 66219, United States
  • Menorah Medical Center
    Overland Park, Kansas 66209, United States
  • University of Kansas Cancer Center-Overland Park
    Overland Park, Kansas 66210, United States
  • Saint Luke's South Hospital
    Overland Park, Kansas 66213, United States
  • University of Kansas Hospital-Westwood Cancer Center
    Westwood, Kansas 66205, United States
  • Cancer Center of Kansas-Wichita Medical Arts Tower
    Wichita, Kansas 67208, United States
  • Ascension Via Christi Hospitals Wichita
    Wichita, Kansas 67214, United States
  • Cancer Center of Kansas - Wichita
    Wichita, Kansas 67214, United States
  • Saint Joseph Radiation Oncology Resource Center
    Lexington, Kentucky 40504, United States
  • Saint Joseph Hospital East
    Lexington, Kentucky 40509, United States
  • Jewish Hospital
    Louisville, Kentucky 40202, United States
  • UofL Health Medical Center Northeast
    Louisville, Kentucky 40245, United States
  • Ochsner Health Center-Summa
    Baton Rouge, Louisiana 70809, United States
  • Medical Center of Baton Rouge
    Baton Rouge, Louisiana 70816, United States
  • Ochsner High Grove
    Baton Rouge, Louisiana 70836, United States
  • Ochsner Medical Center Jefferson
    New Orleans, Louisiana 70121, United States
  • Bronson Battle Creek
    Battle Creek, Michigan 49017, United States
  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
    Grand Rapids, Michigan 49503, United States
  • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
    Grand Rapids, Michigan 49503, United States
  • Trinity Health Grand Rapids Hospital
    Grand Rapids, Michigan 49503, United States
  • Bronson Methodist Hospital
    Kalamazoo, Michigan 49007, United States
  • West Michigan Cancer Center
    Kalamazoo, Michigan 49007, United States
  • Beacon Kalamazoo
    Kalamazoo, Michigan 49048, United States
  • Trinity Health Muskegon Hospital
    Muskegon, Michigan 49444, United States
  • Corewell Health Lakeland Hospitals - Niles Hospital
    Niles, Michigan 49120, United States
  • Cancer and Hematology Centers of Western Michigan - Norton Shores
    Norton Shores, Michigan 49444, United States
  • Corewell Health Reed City Hospital
    Reed City, Michigan 49677, United States
  • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
    Saint Joseph, Michigan 49085, United States

Showing the first 100 of 254 sites. Choose a country and city above to see the rest.

09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2018 to primary completion in Jun 2022, 47 months.

Results were first posted in Feb 2024, 1 year 8 months after primary completion.

Of 33 phase 2 interventional studies under Carcinoma, Merkel Cell, half reached primary completion within 92 months of starting (the median), counting those still running; a quarter within 47 and three quarters within 138. This study's 47 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 5, 2017
First posted
Oct 9, 2017
StartActual
Jun 12, 2018
Primary completionActual
Jun 7, 2022
CompletionActual
Feb 19, 2026
Results first posted
Feb 8, 2024
Last update
Aug 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03304639
Responsible party
Sponsor
First posted
Oct 9, 2017
Start date
Jun 12, 2018
Primary completion
Jun 7, 2022
Completion
Feb 19, 2026
Results posted
Feb 8, 2024
Last update
Aug 25, 2026

Study contacts

Jason J Luke
principal investigator · Alliance for Clinical Trials in Oncology

Oversight

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

Not currently enrolling

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

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