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TerminatedNCT03294694Updated May 31, 2025

Ribociclib + PDR001 in Breast Cancer and Ovarian Cancer

A Phase 1 interventional study of Ribociclib and PDR001 in Metastatic Hormone-Receptor-Positive (HR+) Breast Cancer, HER2-Negative Breast Cancer and Metastatic Epithelial Ovarian Cancer, sponsored by Dana-Farber Cancer Institute. Terminated at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-31.

Sponsored by Dana-Farber Cancer Institute · Phase 1, Interventional, and Treatment

Why this study was terminated
Safety Implications

From the registry’s dates

  • Primary completion was Oct 2020, 6 years 1 month ago, and no results have been posted to the registry.

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Phase
Phase 1
Study type
Interventional
Enrollment
33
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

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

Among 142 studies in Breast Neoplasms by Dana-Farber Cancer Institute — 15 open to participants now, 43 under way, none of them phase 3. Breast Neoplasms · Dana-Farber Cancer Institute.

Enrollment
88th of 132
33 · median 50
Started
2017
with 11 others
Phase 1
18 of 142
1 open now
Registered
82nd of 142
by date

Among the 142 studies in Breast Neoplasms by Dana-Farber Cancer Institute, this one is the 88th largest by enrollment of the 132 interventional ones that give a count, is one of 12 that started in 2017, is one of 18 in phase 1, and was the 82nd registered.

Breast Neoplasms

14,832 studies on the registry are indexed under Breast Neoplasms; 3,320 are open to participants now.

Browse Breast Neoplasms studies →

Open to participants now

15 of the 142 studies in Breast Neoplasms by Dana-Farber Cancer Institute are open now, in 2 countries. Recruiting first, the newest first:

10 more — sign in →

By country, each count listing its studies:

United States14
Rwanda2

All 15 open studies →

Where they have run

United States137
Rwanda2
Canada1

Who these studies take

Of the 2,399 Breast Neoplasms studies recruiting now, 1,570 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.

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

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 142 studies in Breast Neoplasms by Dana-Farber Cancer Institute, or all of them as a file.
02

Study summary

This clinical trial is studying the drug Ribociclib (LEE011) in combination with an immunotherapy drug called PDR001 (a therapy that uses the body's own immune system to control cancer) as a possible treatment for metastatic hormone-receptor-positive (HR+), HER2-negative breast cancer (in combination with fulvestrant) or metastatic epithelial ovarian cancer.

The names of the medications involved in this study are:

  • Ribociclib (LEE011)
  • PDR001
  • Fulvestrant
Read the detailed description
  • This research study is a Phase I clinical trial, which tests the safety of an investigational combination of drugs (LEE011 with PDR001), and tries to define the appropriate dose of the above combination of investigational drugs to use for further studies. "Investigational" means that the intervention is being studied.
  • The FDA (the U.S. Food and Drug Administration) has approved LEE011 as a treatment for hormone receptor positive metastatic breast cancer.
  • The FDA has not approved PDR001 as treatment for any type of cancer.
  • The FDA has approved fulvestrant as a treatment for hormone receptor positive metastatic breast cancer.

  • When given separately these medications work in different ways to try and stop cancer cells from growing and spreading.

    • LEE011 is a drug designed to block certain proteins called cyclin-dependent kinases (CDKs) that are required for cells to divide. These proteins may also control the ability of certain cancers to grow.
    • PDR001 is an antibody. Antibodies are proteins usually produced by the body that help protect against foreign matter, such as bacteria and viruses. PDR001 blocks a protein called PD-1 which is present on cells called T-lymphocytes, which are involved in the immune response. PDR001 is being tested to see if it will allow the body's immune system to work against tumor cells. Other studies have shown that blocking PD-1 may result in reduced tumor cell growth in a variety of solid tumors.
    • Fulvestrant is an estrogen receptor antagonist that is indicated for the treatment of postmenopausal women with HR+ MBC.
  • In this research study, the investigators are looking for a safe and tolerable dose of LEE011 that can be given in combination with PDR001 for participants with metastatic hormone-receptor-positive (HR+), HER2-negative breast cancer (in combination with fulvestrant) or metastatic epithelial ovarian cancer.

ELIGIBILITY FOR COHORT A DOSE ESCALATION (Ribociclib + PDR001):

  • Hormone receptor (HR)-positive, HER2-negative metastatic breast cancer according to ASCO CAP Guidelines.

    • Participants may have received any number of previous endocrine/hormonal lines of therapy in the metastatic setting, as long as the last dose is ≥ 14 days prior to registration.
    • Participants may have received any number of prior lines of chemotherapy for advanced breast cancer as long as the last dose is ≥ 21 days prior to registration.
    • Prior therapy with biologics and investigational drugs is allowed as long as the last dose is ≥ 21 days prior to registration.
    • Prior CDK4/6 inhibition is allowed. Participants who have had prior ribociclib must have received treatment at full-dose without any dose-reductions. The last dose is required to be ≥ 21 days prior to registration
    • No prior PD1/PDL1/CTLA4 inhibitors
    • Participants may have received radiotherapy for palliative purposes but must have completed treatment ≥ 14 days prior to registration and not be experiencing > grade 1 treatment related toxicities.
    • Men are eligible, as long as on a GnRH agonist for at least 6 weeks prior to study entry. Men MUST remain on the GnRH agonist for the duration of protocol treatment.
    • Evaluable or measurable disease by RECIST 1.1.

  • Metastatic epithelial ovarian cancer, fallopian tube or peritoneal cancer. All histologies (including serous, mucinous, endometrioid, clear cell, MMMTs and mix histologies) and tumor grades are eligible

    • Must have received a first-line platinum-based therapy and have disease that is platinum-resistant.

      --- Platinum-resistant disease is defined as disease relapse within 2 to 6 months of prior platinum-based chemotherapy.

    • There is no limit to the number of lines of prior chemotherapy, biology or hormonal therapy regimens.
    • No prior PD1/PDL1/CTLA4 inhibitors
    • Evaluable or measurable disease by RECIST 1.1.

ELIGIBILITY FOR COHORT A DOSE EXPANSION (Ribociclib + PDR001):

  • Metastatic epithelial ovarian cancer, fallopian tube or peritoneal cancer. All histologies (including serous, mucinous, endometrioid, clear cell, MMMTs and mixed histologies) and tumor grades are eligible.

    • Must have received a first-line platinum-based chemotherapy regimen and have relapsed despite standard therapy.

    • Must have received a first-line platinum-based therapy and have disease that is platinum-resistant.

      --- Platinum-resistant disease is defined as disease relapse within 2 to 6 months of prior platinum-based chemotherapy.

    • There is no limit to the number of lines of prior chemotherapy, biology or hormonal therapy regimens.
    • Patients may have received any number of previous endocrine / hormonal lines of therapy in the metastatic setting, as long as the last dose is ≥ 14 days prior to first dose of study treatment.

  • Prior therapy with biologics and investigational drugs is allowed, as long as the last dose is ≥ 21 days prior to first dose of study treatment.

    • No prior CDK4/6 inhibitors.
    • No prior PD1/PDL1/CTLA4 inhibitors.
    • Measurable disease by RECIST 1.1.
    • Participants with accessible tumor lesion(s) must be willing to undergo two research biopsies: one prior to treatment initiation and one after 7 weeks of protocol therapy. Participants who undergo an attempted on-treatment research biopsy and in whom inadequate tissue is obtained are still eligible to receive protocol therapy. They will not be required to undergo a repeat research biopsy attempt. If a biopsy-accessible participant has had a biopsy within 30 days of treatment initiation for clinical purposes, they may choose to submit an archived specimen from this procedure instead.

ELIGIBILITY FOR COHORT B SAFETY RUN-IN (Ribociclib + PDR001 + Fulvestrant):

  • Hormone receptor (HR)-positive, HER2-negative metastatic breast cancer according to ASCO CAP Guidelines.
  • Men are eligible, as long as on a GnRH agonist for at least 6 weeks prior to study entry. Men MUST remain on the GnRH agonist for the duration of protocol treatment.

  • Women must be postmenopausal as defined as:

    -- Age >60 years or Age >45 with intact uterus and amenorrhea for >12 consecutive months or Follicle stimulating hormone (FSH) levels within postmenopausal range according to the ranges established by the testing facility or Premenopausal women who have been on a GnRH agonist for at least 6 weeks prior to study entry. Women in this group MUST remain on the GnRH agonist for the duration of protocol treatment or Status post bilateral oophorectomy, after adequate healing post-surgery

  • Evaluable or measurable disease by RECIST 1.1.
  • Prior CDK4/6 inhibition is allowed. Participants who have had prior ribociclib must have received treatment at full-dose without any dose-reductions. The last dose is required to be ≥ 21 days prior to registration

  • Prior hormonal therapy:

    • Prior therapy with Fulvestrant is allowed
    • Participants may have received any number of previous endocrine/hormonal lines of therapy in the metastatic setting, as long as the last dose is ≥ 14 days prior to registration.
  • Participants may have received chemotherapy for advanced breast cancer as long as the last dose is ≥ 21 days prior to registration.
  • Prior therapy with biologics and investigational drugs is allowed as long as the last dose is ≥ 21 days prior to registration.
  • Participants may have received radiotherapy for palliative purposes but must have completed treatment ≥ 14 days prior to registration and not be experiencing > grade 1 treatment related toxicities.

ELIGIBILITY FOR COHORT B DOSE EXPANSION (Ribociclib + PDR001 + Fulvestrant):

  • Hormone receptor (HR)-positive, HER2-negative metastatic breast cancer according to ASCO CAP Guidelines.
  • Men are eligible, as long as on a GnRH agonist for at least 6 weeks prior to study entry. Men MUST remain on the GnRH agonist for the duration of protocol treatment.

  • Women must be postmenopausal as defined as:

    -- Age >60 years or Age >45 with intact uterus and amenorrhea for >12 consecutive months or Follicle stimulating hormone (FSH) levels within postmenopausal range according to the ranges established by the testing facility or Premenopausal women who have been on a GnRH agonist for at least 6 weeks prior to study entry. Women in this group MUST remain on the GnRH agonist for the duration of protocol treatment or Status post bilateral oophorectomy, after adequate healing post-surgery

  • Prior hormonal therapy:

    • Participants may have received any number of previous endocrine/hormonal lines of therapy in the metastatic setting, as long as the last dose is ≥ 14 days prior to registration.
    • No prior fulvestrant
  • Participants may have received up to one prior line of chemotherapy for advanced breast cancer as long as the last dose is ≥ 21 days prior to registration.
  • Prior therapy with biologics and investigational drugs is allowed as long as the last dose is ≥ 21 days prior to registration.
  • No prior CDK4/6 inhibitors
  • No prior PD1/PDL1/CTLA4 inhibitors
  • Participants may have received radiotherapy for palliative purposes but must have completed treatment ≥ 14 days prior to registration and not be experiencing > grade 1 treatment-related toxicities.
  • Measurable disease by RECIST 1.1.
  • Participants with accessible tumor lesion(s) must be willing to undergo two research biopsies: one prior to treatment initiation and one after 7 weeks of protocol therapy. Participants who undergo an attempted on-treatment research biopsy and in whom inadequate tissue is obtained are still eligible to receive protocol therapy. They will not be required to undergo a repeat research biopsy attempt. If a biopsy-accessible participant has had a biopsy within 30 days of treatment initiation for clinical purposes, they may choose to submit an archived specimen from this procedure instead.
03

Conditions studied

  • Metastatic Hormone-Receptor-Positive (HR+) Breast Cancer
  • HER2-Negative Breast Cancer
  • Metastatic Epithelial Ovarian Cancer

Keywords

  • Metastatic Hormone-Receptor-Positive (HR+) Breast Cancer
  • HER2-Negative Breast Cancer
  • Metastatic Epithelial Ovarian Cancer
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

  • Cohort A Dose Escalation (Ribociclib + PDR001) Eligibility can be found in Detailed Description Section
  • Cohort B Safety Run-In (Ribociclib + PDR001 + Fulvestrant) Eligibility can be found in Detailed Description Section
  • Cohort A Dose Expansion (Ribociclib + PDR001) Eligibility can be found in the Detailed Description Section
  • Expansion Cohort B (Ribociclib + PDR001 + Fulvestrant Eligibility can be found in the Detailed Description Section
  • Performance Status 0-1

  • Participants must have normal organ and marrow function, as defined below:

    • ≥1,500/mcL
    • ≥100,000/mcL
    • total ≥ 9 g/dL (may be post-transfusion)
    • total ≤1.5 x institutional (IULN)
    • (SGOT)/ALT(SGPT) ≤2.5 × IULN or ≤5 × IULN for participants with liver
    • creatinine ≤1.5 x IULN or ≥ 60 ml/min/1.73m2 for subjects with creatinine levels above institutional normal
    • ≤ 1.5
    • estimated (eGFR) ≥ 30 mL/min/1.73 by either Cockcroft-Gaultor CKD-EPI
    • baseline ≤ 450 msec
  • Age > 18 years
  • Women of , defined as all women physiologically capable of becoming pregnant, must be willing to use a highly effective method of during dosing and for 150 days after the last dose of PDR001.

Note: Highly effective contraception methods include:

  • Total abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
  • Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment
  • For female participants, male sterilization (at least 6 months prior to screening).

  • Placement of an intrauterine device (IUD) or intrauterine system (IUS).

    • Sexually active males must be willing to use a condom during intercourse while taking the study drug and for 21 days after stopping the study drug and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid.
    • Willingness to provide . If sample is not available, a biopsy should be considered in patients with safely accessible disease. Participants who undergo an attempted research biopsy procedure for the purpose of this protocol, and in whom inadequate tissue is obtained, are not required to undergo repeat biopsy in order to continue on protocol.
    • Ability to understand and the willingness to sign a written document.

Exclusion criteria

Exclusion Criteria:

  • Participants cannot have been treated on a prior interventional, study within 2 weeks of the first dose of study treatment.
  • Participants cannot receive treatment with any other investigational agents during protocol therapy.
  • Use of hematopoietic colony-stimulating growth factors (e.g. G-CSF, GMCSF, M-CSF) ≤2 weeks prior start of study drug. An erythroid stimulating agent is allowed as long as it was initiated at least 2 weeks prior to the first dose of study treatment.
  • History of severe reactions to other mAbs
  • Participants requiring chronic treatment with systemic therapy, other than replacement-dose steroids in the setting of adrenal insufficiency within 7 days of treatment initiation. Topical, inhaled, nasal and ophthalmic steroids are allowed. Physiologic doses of steroids are acceptable.
  • Participants receiving systemic treatment with any medication (other than steroids as described above).
  • Patient is currently receiving warfarin or other coumadin-derived anticoagulant for treatment, prophylaxis, or otherwise. Therapy with heparin, low molecular weight heparin (LMWH), coumadin or fondaparinux is allowed.
  • Use of any within 4 weeks of initiation of study treatment.
  • Major surgery within 2 weeks of the first dose of study treatment (mediastinoscopy, insertion of a central venous access device, and insertion of a feeding tube are not considered major surgery).
  • Participants with active disease. Participants with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
  • Presence of ≥ grade 2 toxicity (CTCAE Grade 2 peripheral neuropathy and ototoxicity and any grade alopecia are allowed).

  • Participants with uncontrolled intercurrent illness including, but not limited to:

    • , uncontrolled heart disease and/or cardiac repolarization abnormalities, including any of the following:

      • History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) or symptomatic pericarditis within 6 months prior to screening
      • History of documented congestive heart failure ( functional classification III-IV)
      • Documented cardiomyopathy
      • (LVEF) \<50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO) within six months prior to beginning protocol therapy.
      • Clinically significant cardiac arrhythmias (e.g. ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g. bifascicular block, Mobitz type II and third-degree AV block)
      • Long syndrome or family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:
      • Risk factors for Torsades de Pointe (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia.
      • Concomitant use of medication(s) with a known risk to prolong the QT interval and/or known to cause Torsades de Pointe that cannot be discontinued (within 5 half-lives or 7 days prior to starting study drug) or replaced by safe alternative medication
      • Systolic blood pressure (SBP) >160 mmHg or \<90 mmHg at screening
      • Impairment of gastrointestinal function or who have gastrointestinal disease that may significantly alter the absorption of study drugs (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea or malabsorption syndrome).
      • Patient with liver disease and score B or C.
    • Individuals with a history of a second are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and non-melanoma cancer of the skin. Patients with other cancers diagnosed within the past 5 years and felt to be at low risk of recurrence should be discussed with the study sponsor to determine eligibility.
    • Participants with known may be enrolled in this study if radiation therapy and/or surgery have been completed with a minimum of 4 weeks of stable disease demonstrated on evaluation by MRI. Such participants must no longer require treatment with corticosteroids or enzyme inducing anti-epileptic medications for their CNS disease.
    • Participants with current pneumonitis.
    • Participants known to be -positive or known to have active or C.
    • Pregnant or lactating women. A negative pregnancy test in women of must be documented within 7 days before the first dose of study medication.
    • Any condition that would prevent the patient's participation in the clinical study due to safety concerns, compliance with clinical study procedures or interpretation of study results.
    • Active infection requiring systemic antibiotic therapy.
    • Systemic anti-cancer therapy within 2 weeks of the first dose of study treatment. For cytotoxic agents that have major delayed toxicity, e.g. mitomycin C and nitrosoureas, 4 weeks is indicated as . For patients receiving anticancer immunotherapies such as antagonists, 3 weeks is indicated as the washout period
    • Participants who have received thoracic radiotherapy to lung fields ≤ 4 weeks prior to starting the study treatment or patients who have not recovered from radiotherapy-related toxicities. For all other anatomic sites (including radiotherapy to thoracic vertebrae and ribs) radiotherapy ≤ 2 weeks prior to starting the study treatment or has not recovered from radiotherapy-related toxicities. Palliative radiotherapy for bone lesions ≤ 2 weeks prior to starting study treatment is allowed.
Terms in these criteria, in plain language(32)

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.

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.

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.

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.

Metastases

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

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

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.

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.

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.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

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.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    Ribociclib and PDR001 (Cohort A)

    * The treatment regimen is defined as ribociclib + PDR001. * Treatment will be administered on an outpatient basis. * The study will use a 3 + 3 dose escalation design to determine the MTD/RP2D. * Three to six evaluable patients will be enrolled in each cohort in the dose escalation phase. * Once the RP2D of the combination of ribociclib + PDR001 is determined, there will be an expansion cohort. * Cohort A expansion will assess the combination of ribociclib + PDR001 in 12 patients with metastatic ovarian cancer.

    Drug: Ribociclib · Drug: PDR001

  • Experimental
    Ribociclib, PDR001 and Fulvestrant (Cohort B)

    * The treatment regimen is defined as ribociclib + PDR001 + fulvestrant . * Treatment will be administered on an outpatient basis. * There will be a safety run-in using the MTD/RP2D of ribociclib + PDR001 from Cohort A with the addition of fulvestrant in an initial 6-12 patients. * Once the safety of the combination of ribociclib + PDR001 + fulvestrant is established, there will be an expansion cohort. * Cohort B expansion will assess the combination of ribociclib + PDR001 + fulvestrant in 24 patients with hormone receptor-positive metastatic breast cancer (HR+ MBC).

    Drug: Ribociclib · Drug: PDR001 · Drug: Fulvestrant

Interventions

  • DrugRibociclib

    Each treatment cycle lasts 28 days. Ribociclib, 1 time per day by mouth for 21 days, followed by 1-week of rest (28-day cycle)

    Also known as: Kisqali, LEE011, LEE-011

  • DrugPDR001

    Each treatment cycle lasts 28 days. (PDR001) will be administered once every 28 days (by intravenous infusion) over about 30 minutes (or up to 2 hours, if necessary) for the first infusion and over about 30 minutes for all following infusions.

  • DrugFulvestrant

    Each treatment cycle lasts 28 days. Fulvestrant will be administered during Cycle 1 on days 1 and 15, and then on day 1 of each 28-day cycle thereafter.

    Also known as: Faslodex, ICI 182,780, ZD9238

06

What researchers measure

Primary outcomes

  1. Cohort A: MTD/RP2D of the Combination of Ribociclib + PDR001

    Toxicity will be graded according to NCI CTCAE, Version 4.0.

    Time frame: 4 weeks

  2. Cohort B: MTD/RP2D of the Combination of Ribociclib + PDR001 + Fulvestrant

    Toxicity will be graded according to NCI CTCAE, Version 4.0.

    Time frame: 4 weeks

Secondary outcomes

  1. Number of Participants with Adverse Events

    Toxicity will be graded according to NCI CTCAE, Version 4.0.

    Time frame: All participants will be evaluable for toxicity from the time of their first treatment with any study agent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

  2. Objective Response Rate

    ORR is defined as the proportion of patients with complete response or partial response by RECIST 1.1 and immune-related RECIST (irRECIST)

    Time frame: 2 Years

07

Study locations

3 sites
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Brigham and Women's Hospital
    Boston, Massachusetts 02115, United States
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02215, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2017 to primary completion in Oct 2020, 35 months.

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

Registered
Sep 19, 2017
First posted
Sep 27, 2017
StartActual
Nov 8, 2017
Primary completionActual
Oct 14, 2020
CompletionActual
Oct 14, 2020
Last update
May 31, 2025
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 May 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03294694
Lead sponsor
Dana-Farber Cancer Institute
Collaborators
Novartis
Responsible party
Sara Tolaney, MD (Principal Investigator, Dana-Farber Cancer Institute) — Principal investigator
First posted
Sep 27, 2017
Start date
Nov 8, 2017
Primary completion
Oct 14, 2020
Completion
Oct 14, 2020
Last update
May 31, 2025

Study contacts

Sara Tolaney, MD
principal investigator · Dana-Farber Cancer Institute

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 May 2025. You cannot join it, but the record below documents what was studied.

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