ClinicalTrials.gg
CompletedNCT03452332Updated Sep 13, 2023

Stereotactic Body Radiation Therapy, Tremelimumab and Durvalumab in Treating Participants With Recurrent or Metastatic Cervical, Vaginal, or Vulvar Cancers

A Phase 1 interventional study of Durvalumab and Laboratory Biomarker Analysis in Advanced Cervical Adenocarcinoma, Advanced Vaginal Carcinoma and Advanced Vulvar Carcinoma, sponsored by M.D. Anderson Cancer Center. Completed at 2 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-13.

Sponsored by M.D. Anderson Cancer Center · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Aug 2023, 3 years 3 months ago, and no results have been posted to the registry.

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Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 59 studies in Uterine Cervical Neoplasms by M.D. Anderson Cancer Center — 8 open to participants now, 17 under way, none of them phase 3. Uterine Cervical Neoplasms · M.D. Anderson Cancer Center.

Enrollment
26th of 35
20 · median 40
Started
2018
with 5 others
Phase 1
8 of 59
2 open now
Registered
38th of 59
by date

Among the 59 studies in Uterine Cervical Neoplasms by M.D. Anderson Cancer Center, this one is the 26th largest by enrollment of the 35 interventional ones that give a count, is one of 6 that started in 2018, is one of 8 in phase 1, and was the 38th registered.

Uterine Cervical Neoplasms

2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.

Browse Uterine Cervical Neoplasms studies →

Open to participants now

8 of the 59 studies in Uterine Cervical Neoplasms by M.D. Anderson Cancer Center are open now, in 2 countries. Recruiting first, the newest first:

3 more — sign in →

By country, each count listing its studies:

All 8 open studies →

Who these studies take

Of the 474 Uterine Cervical Neoplasms studies recruiting now, 243 (51%) set no upper age limit and 191 (40%) stop at 75 or younger; 20 take children under 18; 69 take healthy volunteers.

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

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02

Study summary

This phase I trial studies how well stereotactic body radiation therapy works in combination with tremelimumab and durvalumab in treating participants with cervical, vaginal, or vulvar cancers that have come back (recurrent) or spread to other areas of the body (metastatic). Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Immunotherapy with monoclonal antibodies, such as tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Giving stereotactic body radiation therapy, tremelimumab, and durvalumab may work better in treating participants with cervical, vaginal, or vulvar cancers.

Read the detailed description

PRIMARY OBJECTIVE:

I. To determine the safety, and tolerability of combined immune checkpoint blockade with 3 fractions of stereotactic body radiation therapy (stereotactic ablative radiotherapy [SABR]) of up to two metastatic lesions in patients with recurrent and or metastatic cervical, vaginal, or vulvar cancer.

SECONDARY OBJECTIVES:

I. To evaluate clinical response rates and assess toxicities of treatment to durvalumab combined with tremelimumab with 3 fractions of SABR of at least one and up to two metastatic lesions in patients with recurrent/metastatic cervical, vaginal, or vulvar cancer.

II. To estimate progression-free survival, overall survival, and time to next treatment.

EXPLORATORY OBJECTIVES:

I. To evaluate potential biomarkers of immune response to combined immune-checkpoint inhibition with SABR and correlate this with clinical response to treatment.

II. To evaluate potential biomarkers of immune response including cervical and rectal microbial diversity, cervical immune cell infiltration and peripheral immune cell activation as correlates of clinical response to treatment.

OUTLINE:

Participants receive tremelimumab intravenously (IV) over 1 hour followed by durvalumab IV over 1 hour on day 1 of each cycle. Participants also undergo SABR over 30-45 minutes on days 8, 10, and 12 of cycle 1. Treatment with tremelimumab repeats every 4 weeks for up to 4 cycles, and treatment with durvalumab repeats every 4 weeks for up to 8 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, participants are followed up at 30 days, at 2, 3, 4, 6, 8, 10, and 12 months, and then every 6 months thereafter.

03

Conditions studied

  • Advanced Cervical Adenocarcinoma
  • Advanced Vaginal Carcinoma
  • Advanced Vulvar Carcinoma
  • Human Papillomavirus-Related Cervical Squamous Cell Carcinoma
  • Human Papillomavirus-Related Vulvar Squamous Cell Carcinoma
  • Metastatic Cervical Adenocarcinoma
  • Metastatic Cervical Carcinoma
  • Metastatic Cervical Squamous Cell Carcinoma, Not Otherwise Specified
  • Metastatic Vaginal Adenocarcinoma
  • Metastatic Vaginal Carcinoma
  • Metastatic Vulvar Carcinoma
  • Recurrent Cervical Adenocarcinoma
  • Recurrent Cervical Carcinoma
  • Recurrent Cervical Squamous Cell Carcinoma, Not Otherwise Specified
  • Recurrent Vaginal Carcinoma
  • Recurrent Vulvar Carcinoma
  • Stage III Cervical Cancer AJCC v8
  • Stage III Vaginal Cancer AJCC v8
  • Stage III Vulvar Cancer AJCC v8
  • Stage IIIA Cervical Cancer AJCC v8
  • Stage IIIA Vulvar Cancer AJCC v8
  • Stage IIIB Cervical Cancer AJCC v8
  • Stage IIIB Vulvar Cancer AJCC v8
  • Stage IIIC Vulvar Cancer AJCC v8
  • Stage IV Cervical Cancer AJCC v8
  • Stage IV Vaginal Cancer AJCC v8
  • Stage IV Vulvar Cancer AJCC v8
  • Stage IVA Cervical Cancer AJCC v8
  • Stage IVA Vaginal Cancer AJCC v8
  • Stage IVA Vulvar Cancer AJCC v8
  • Stage IVB Cervical Cancer AJCC v8
  • Stage IVB Vaginal Cancer AJCC v8
  • Stage IVB Vulvar Cancer AJCC v8
  • Vaginal Squamous Cell Carcinoma, Not Otherwise Specified
  • Vulvar Adenocarcinoma
  • Vulvar Squamous Cell Carcinoma
04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Written obtained from subject prior to any protocol related procedures
  • Performance status (ECOG) 0-2.
  • Body weight > 30 kg
  • Must have an average of 6 months
  • Patient is able and willing to comply with protocol and study procedures for the duration of the study including undergoing treatment and scheduled visits and examinations including follow-up visits
  • Histological diagnosis of recurrent or cervical, vaginal, or vulvar cancer or an unknown pelvic most likely to have arisen from these sites as determined clinically by the treating physicians (i.e. squamous cell carcinoma or adenocarcinoma that is high risk [HR] human papillomavirus positive [HPV]+, but not limited to this example)
  • Metastatic disease in at least two distinct lesions (including the index lesion to be treated) with at least one site outside of the radiation field and evaluable by (RECIST) criteria for evaluation of response
  • At least one index lesion to be treated measuring 1 cm amenable to hypofractionated radiation therapy
  • Staging computed tomography (CT) scans done prior to enrollment
  • Have had at least one line of prior platinum-based systemic chemotherapy once diagnosed with recurrence or metastatic disease if primary cervical cancer. If a patient has primary vulvar or vaginal cancer, there is not a requirement.
  • May have received 1 prior biologic regimen (i.e. avastin) but not within 4 weeks of enrollment
  • Full recovery from the acute effects of prior treatments, defined as effects having resolved to National Cancer Institute (NCI) (CTCAE) version (v) 4.03 grade 0 or 1 with the exception of alopecia and certain laboratory values as outlined below; subjects with irreversible toxicity that is not reasonably expected to be exacerbated by durvalumab and tremelimumab may be included (e.g., hearing loss, neuropathy) upon approval of the principal investigator (PI)
  • In patients with central nervous system (CNS) metastases, metastases must be asymptomatic at the time of day 1 of the study and meet the following criteria:

    • should have been treated with either whole brain radiation therapy (WBRT), stereotactic radiosurgery (SRS)/gamma-knife, or surgical resection;
    • At least 28 days without progression of CNS metastases as evidenced by magnetic resonance imaging (MRI) or CT from last day of treatment with radiation to the CNS metastases;
    • At least 3 months from surgical resection (if had surgery) with stability on MRI brain at enrollment;
    • At least 14 days since last dose of ;
    • Must not have or cord compression
  • (AST) and alanine aminotransferase (ALT) =\< 2.5 x (ULN); for subjects with liver metastasis, ALT and AST =\< 5 x ULN within 3 weeks prior to initial treatment
  • Total =\< 1.5 x ULN except in patients with documented Gilbert's syndrome or liver metastasis, who must have a baseline total bilirubin =\< 3.0 mg/dl within 3 weeks prior to initial treatment
  • Serum (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance within 3 weeks prior to initial treatment
  • Negative screening test results for , , and
  • (ANC) >= 1,500 cells/ul without growth factor support prior to initial treatment
  • >= 9 g/dL prior to initial treatment
  • count >= 100,000 platelets/ul prior to initial treatment
  • Subjects must either be of non- (ie, by history; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum or urine pregnancy test upon study entry; women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause; the following age-specific requirements apply:

    • Women \< 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy); they would also be considered had radiation-induced or chemotherapy-induced menopause with last menses > 1 year ago
    • Women >= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses > 1 year ago, had chemotherapy-induced menopause with last menses > 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy)
    • Women of any age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced or chemotherapy-induced menopause
  • Females of who are sexually active with a nonsterilized male partner must use highly effective method of from the time of screening, and must agree to continue using such precautions for 180 days after the final dose of durvalumab and tremelimumab; cessation of contraception after this point should be discussed with a responsible physician; they must also refrain from egg cell donation for 180 days after the final dose of durvalumab and tremelimumab

    • Note: A highly effective method of contraception is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly; the acceptable methods of contraception include barrier methods (male condom plus spermicide, copper T intrauterine device, levonorgesterel-releasing intrauterine system) or hormonal methods (implants, hormone shot or injection, combined pill, minipill, patch)

Exclusion criteria

Exclusion Criteria:

  • Involvement in the planning and/or conduct of the study
  • Previous enrollment in the present study
  • Female patients who are pregnant or breastfeeding or male or female patients of who are not willing to employ effective from screening to 90 days after the last dose of durvalumab monotherapy or 180 days after the last dose of durvalumab + tremelimumab combination therapy
  • Prior treatment with an , including tremelimumab PD-1 or PD-L1 inhibitor, including durvalumab
  • Prior oncology vaccine therapy
  • Prior radiation treatment to the index lesion to be treated
  • Prior radiation which overlaps and precludes hypofractionated treatment to the index lesion
  • Treatment with other agent within 4 weeks to the first dose of tremelimumab or durvalumab
  • Concomitant therapy with any of the following: interleukin-2 (IL-2), interferon, or other non-study immunotherapy regimens; cytotoxic chemotherapy; agents; other investigational therapies; all such therapies must have been discontinued > 4 weeks
  • Any unresolved toxicity ( grade \< 2) from previous anti-cancer therapy; (subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripherally neuropathy)
  • Any prior grade >= 3 immune-related adverse event (imAE) while receiving any previous immunotherapy agent, or any unresolved imAE > grade 1
  • Treatment with a vascular endothelial growth factor (VEGF) inhibitor within the last 6 weeks
  • Major surgical procedure (as defined by the treating physician) within 28 days prior to the first dose of durvalumab and tremelimumab or still recovering from prior surgery
  • Active cardiac disease defined as unstable angina, uncontrolled hypertension, myocardial infarction in the last six months (unless successfully treated with coronary artery bypass grafting [CABG] or percutaneous transluminal coronary angioplasty [PTCA]), uncontrolled arrhythmia, or symptomatic congestive heart failure; > 3 heart-related hospitalizations in the past year
  • Mean corrected for heart rate (QTc) >= 470 ms calculated from 3 (ECGs) using Fridericia's correction from triplicate ECGs in those patients who have an initial abnormal EKG on screening
  • Severe (COPD) requiring > 3 hospitalizations in the past year
  • Active or prior documented or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]); the following are exceptions to this criterion:

    • Patients with vitiligo or alopecia;
    • Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement;
    • Any chronic skin condition that does not require systemic therapy;
    • Patients without active disease in the last 5 years may be included but only after consultation with the study physician;
    • Patients with celiac disease controlled by diet alone
  • Active or prior documented interstitial lung disease
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab and tremelimumab with the exceptions of intranasal and inhaled , systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent, or steroids used transiently to control contrast agent allergies for radiographic studies
  • History of allogeneic organ transplant
  • History of to durvalumab or tremelimumab or any CTLA4, PD1, or PDL-1 inhibitor
  • Receipt of within 30 days prior to study entry or within 30 days of receiving durvalumab or tremelimumab
  • Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis [TB] testing in line with local practice), (known positive hepatitis B virus [HBV] surface antigen [HBsAg] result), , or (positive HIV 1/2 antibodies); patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible; patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA)
  • History of prior bowel fistula, ulcerations, or perforations
  • Evidence of progressive or symptomatic central nervous system (CNS) or
  • Uncontrolled inter-current illness, including, but not limited to, ongoing or active infection requiring systemic treatment, current or history of prior radiation induced pneumonitis, interstitial lung disease, or psychiatric illness/social situations that would limit compliance with study requirement or compromise the ability of the subject to give written
  • Other active invasive ; history of non-invasive malignancies such as ductal carcinoma in situ of the breast, non-melanomatous carcinoma of the skin, is allowed, as is history of other invasive malignancy that is in remission for >= 5 years after treatment with curative intent
  • Any medical, psychological, or social condition that, in the opinion of the treating physician would interfere with evaluation of the investigational product or interpretation of subject safety or study results
Terms in these criteria, in plain language(33)

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.

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.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Metastases

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

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.

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.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

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.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

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.

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.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

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.

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.

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.

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).

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.

Reproductive potential

Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.

Criteria about it usually ask 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).

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.

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.

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.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

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.

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.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

05

Study design

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

Study arms

  • Experimental
    Treatment (tremelimumab, durvalumab, SABR)

    Participants receive tremelimumab IV over 1 hour followed by durvalumab IV over 1 hour on day 1 of each cycle. Participants also undergo SABR over 30-45 minutes on days 8, 10, and 12 of cycle 1. Treatment with tremelimumab repeats every 4 weeks for up to 4 cycles, and treatment with durvalumab repeats every 4 weeks for up to 8 cycles in the absence of disease progression or unacceptable toxicity.

    Biological: Durvalumab · Other: Laboratory Biomarker Analysis · Radiation: Stereotactic Radiosurgery · Biological: Tremelimumab

Interventions

  • BiologicalDurvalumab

    Given IV

    Also known as: Imfinzi, Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer, MEDI-4736, MEDI4736

  • OtherLaboratory Biomarker Analysis

    Correlative studies

  • RadiationStereotactic Radiosurgery

    Undergo SABR

    Also known as: Stereotactic External Beam Irradiation, stereotactic external-beam radiation therapy, Stereotactic Radiation Therapy, Stereotactic Radiotherapy, stereotaxic radiation therapy, stereotaxic radiosurgery

  • BiologicalTremelimumab

    Given IV

    Also known as: Anti-CTLA4 Human Monoclonal Antibody CP-675,206, CP-675, CP-675,206, CP-675206, Ticilimumab

06

What researchers measure

Primary outcomes

  1. Incidence of adverse events by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.03

    Will be assessed based on dose limiting toxicities (DLTs) and based on adverse events (AEs) throughout the entire treatment period. In the overall assessment of adverse events, AEs will be tabulated by body system, type and grade, overall and by disease cohort. The number and percentage of patients experiencing at least one grade 3 or higher AE will also be reported.

    Time frame: Up to 3 months after last dose of durvalumab

Secondary outcomes

  1. Response to treatment by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and immune-related response criteria

    This will be measured in both treated and untreated lesions with computed tomography (CT) imaging or other appropriate imaging modalities. Immune-related response is reported as number and percent of patients with two-sided 80% confidence intervals (CI). Because each patient will have multiple lesions, a generalized linear mixed model will be used, if possible, to calculate overall response, as well as response by index or non-index lesion. The depth and duration of response will be depicted using waterfall and swimmer plots.

    Time frame: Up to 1 year

  2. Progression-Free Survival

    To summarize progression free survival we will use Kaplan Meier analysis, reporting the median with confidence interval.

    Time frame: From the start of therapy up to first documented disease progression or death from any cause, assessed up to 1 year

  3. Overall Survival

    To summarize overall survival we will use Kaplan Meier analysis, reporting the median with confidence interval.

    Time frame: From start of therapy to death from any cause, assessed up to 1 year

  4. Time to next treatment (TTNT)

    To summarize time to next treatment we will use Kaplan Meier analysis, reporting the median with confidence interval.

    Time frame: From the end of immune-checkpoint inhibition treatment to institution of next therapy, assessed up to 1 year

07

Study locations

2 sites
  • UT Southwestern/Simmons Cancer Center-Dallas
    Dallas, Texas 75390, United States
  • M D Anderson Cancer Center
    Houston, Texas 77030, United States
08

References and documents

09

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 Jul 2018 to primary completion in Aug 2023, 60 months.

Of 58 non-industry phase 1 interventional studies under Uterine Cervical Neoplasms, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 72. This study's 60 months is close to that.

Counting every sponsor, half of 142 studies reached it within 48 months; a quarter within 27 and three quarters within 70.

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

Registered
Feb 26, 2018
First posted
Mar 2, 2018
StartActual
Jul 18, 2018
Primary completionActual
Aug 11, 2023
CompletionActual
Aug 11, 2023
Last update
Sep 13, 2023
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 Sep 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03452332
Responsible party
Sponsor
First posted
Mar 2, 2018
Start date
Jul 18, 2018
Primary completion
Aug 11, 2023
Completion
Aug 11, 2023
Last update
Sep 13, 2023

Study contacts

Lilie L Lin
principal investigator · M.D. Anderson Cancer Center

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 Sep 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Tremelimumab

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