Well-differentiated/Dedifferentiated LiposarcomaPhase 2NCT04438824
Palbociclib and INCMGA00012 in People With Advanced Liposarcoma
A Phase 2 study testing INCMGA00012 and Palbociclib in people with Well-differentiated/Dedifferentiated Liposarcoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The researchers are doing this study to find out whether combining the study drugs palbociclib and INCMGA00012 is an effective and safe treatment for advanced liposarcoma. "Funding Source - FDA OOPD" Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Well-differentiated/Dedifferentiated Liposarcoma
- What is being tested?
- INCMGA00012 and Palbociclib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 7 sitesUnited States
- Study dates
- 17 Jun 2020to Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of metastatic or unresectable WD/DD liposarcoma. DD liposarcoma must be present. Unresectable is defined as if the primary tumor a) cannot be safely removed surgically or b) would benefit from systemic therapy prior to a surgical approach
- Measurable disease by RECIST 1.1
- Target lesions must not be chosen from a previously irradiated field unless there has been radiographically and/or pathologically documented tumor progression in that lesion prior to enrollment
- Age ≥ 18 years
- ECOG performance status 0 or 1
- Adequate organ and marrow function as defined below (ULN indicates institutional upper limit of normal):
Show all 17Show fewer
- Absolute neutrophil count ≥ 1.5 x 109/L
- Hemoglobin ≥ 8.0 g/dL
- WBC ≥ 3.0 x 109/L
- Platelets ≥ 100 x 109/L
- ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN. Except patients with Gilbert's disease (≤3x ULN)
- AST (SGOT) /ALT (SGPT) ≤ 3 x institutional ULN
- Creatinine Clearance > 30 mL/min (calculated by Cockcroft-Gault method)
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) during the trial period through at least 120 days after the last dose of study treatment.
- Ability to understand and the willingness to sign a written informed consent document.
- Ability to swallow tablets or capsules
- Patients with brain metastasis that have been treated with definitive surgery or radiation, and have been clinically stable for 3 months are eligible
Who cannot join
- Patients who have not recovered from clinically significant adverse events of prior therapy to ≤ NCI CTCAE v5 Grade 1, except alopecia and stable neuropathy, which must have resolved to Grade ≤ 2 or baseline.
- Patients receiving any other investigational agents.
- Patients who have received prior treatment with a selective CDK4 inhibitor or an anti-PD-1/PD-L1 agent
- Uncontrolled intercurrent illness including, but not limited to, known ongoing or active infection, including uncontrolled HIV, active hepatitis B or C, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmias, psychiatric illness/social situations that would limit compliance with study requirements, clinically significant interstitial lung disease or active noninfectious pneumonitis, or active infection requiring systemic therapy
- Patients with a CD4+ count of > 300 and an undetectable viral load who are currently on HAART are eligible for inclusion
- Patients with NYHA class III or IV congestive heart failure within 6 months of study treatment will be excluded
Show all 15Show fewer
- Pregnant women and women who are breast-feeding.
- History or evidence of symptomatic autoimmune disease in past 2 years prior to enrollment.
- Replacement therapy (e.g., thyroxine for hypothyroidism, insulin for diabetes or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment for autoimmune disease
- Prolonged QTcF > 450 ms for men and > 470 ms for women at Screening.
- Patients who have received a live vaccine within 30 days of the start date of the planned study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines are live attenuated vaccines, and are not allowed
- Radiation therapy within 2 weeks prior to study Day 1
- Prior organ transplantation including allogenic stem-cell transplantation
- Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v 5 Grade ≥ 3)
- Patients who require concomitant use of medications that strongly induce or inhibit CYP3A (per section 15.0)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Nassau (Limited protocol activities)
Rockville Centre, New York, 11553
About this study
Official title: A Phase II Study of CDK4/6 Inhibition (Palbociclib) Combined With PD-1 Blockade (INCMGA00012) in Patients With Advanced Well-differentiated Dedifferentiated Liposarcoma
The researchers are doing this study to find out whether combining the study drugs palbociclib and INCMGA00012 is an effective and safe treatment for advanced liposarcoma.
"Funding Source - FDA OOPD"
- Being tested
- INCMGA00012, Palbociclib
- Keywords
- Palbociclib, INCMGA00012, 20-062
- Medical subject headings
- Liposarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCMGA00012Drug
INCMGA00012: 500 mg IV (flat dose) q28 days (+/- 7 days in each cycle)
PalbociclibDrug
Palbociclib:125 mg PO daily for 21 days, followed by 7 days off, q28 days
| Study group | Role | What they receive |
|---|---|---|
| Palbociclib and INCMGA00012 | Experimental | Initial design (safety lead-in and expansion): One treatment cycle will consist of 28 days. Patients in both study phases will start palbociclib on Day 1 and INCMGA00012 on day 15 (+/- 7 days) of each cycle at the following dose schedule: INCMGA00012: 500 mg IV (flat dose) q28 days Palbociclib: 125 mg PO daily for 21 days, followed by 7 days off, q28 days Palbociclib will be taken on Day 1 of each cycle for 21 consecutive days followed by 7 days off (days 22-28 of each Cycle). INCMGA00012 will be administered on Day 15 of (+/- 7 days) each cycle and repeat every 28 days.(No longer using this)
Amended design (Expansion only): One treatment cycle will consist of 28 days. Patients in both study phases will start palbociclib and INCMGA00012 on day 1 of each cycle: 500 mg IV (flat dose) of INCMGA00012 will be administered q28 days concurrently with palbociclib 125 mg PO daily for 21 days, followed by 7 days off, q28 days. Receives: Drug: INCMGA00012; Drug: Palbociclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
confirm the recommended phase two dose (RP2D
DLTs will be assess within the first 6 weeks of the treatment combination . DLT definitions are described in section 15.4, and will be defined using NCI CTCAE v 5.0. If ≤ 1 patient out of 6 has a dose-limiting toxicity, the dosing used in the safety lead-in phase will be declared the recommended phase 2 dose. If ≥ 2 of 6 patients in the safety lead-in experience a DLT, study treatment will be halted and no further patients will be enrolled. If the study is resumed with an alternative dosing schema, a new safety lead-in phase will be completed with the new dosing regimen
Measured: within 6 weeks of treatment
best overall response rate (Phase II)
defined by RECIST 1.1
Measured: by 48 weeks
Secondary outcomes (2)
Safety
Safety will be assessed using CTCAE v 5.0 to define that adverse event profile of the treatment combination and safety events will be tabulated.
Measured: 2 years
overall response rate
as defined by irRECIST
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start17 Jun 2020
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Well-differentiated/Dedifferentiated LiposarcomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a phase II study of palbociclib plus INCMGA00012 in patients with advanced WD/DD liposarcoma.
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Incyte Corporation
- Responsible party
- Sponsor
- Investigators
- Sandra D'Angelo, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04438824
- Sponsor's protocol ID
- 20-062
- Other IDs
- R01FD007528-01
- Status last verified
- Sep 2026
- First submitted
- 17 Jun 2020
- Last updated
- 14 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Publications
Rosenbaum E, Seier K, Gularte-Merida R, Seffar E, Dickson MA, Avutu V, Banks LB, Chan JE, Chi P, Gounder MM, Kelly CM, Keohan ML, Maki RG, Movva S, Reed D, Desir R, Biniakewitz M, Cho JM, Duchemin M, Erinjeri JP, Lefkowitz RA, Koff A, Singer S, Tap W, Qin LX, D'Angelo S. Phase 2 study of palbociclib plus retifanlimab in patients with advanced dedifferentiated liposarcoma. J Immunother Cancer. 2026 May 4;14(5):e014346. doi: 10.1136/jitc-2025-014346.
PubMed 42082272Rosenbaum E, Gularte-Merida R, Seffar E, Lee J, Adamow M, Bradic M, Dickson MA, Avutu V, Banks LB, Chan JE, Chi P, Gounder MM, Kelly CM, Keohan ML, Maki RG, Movva S, Reed DR, Desir R, Biniakewitz M, Erinjeri JP, Lefkowitz RA, Wong P, Antonescu CR, Qin LX, Panageas KS, Shen R, Singer S, Koff A, Tap WD, D'Angelo SP. Tumor and Immune Dynamics Following Sequential CDK4/6 and PD-1 Inhibition: Results from a Phase 2 Study in Dedifferentiated Liposarcoma. Cancer Res Commun. 2026 Feb 1;6(2):437-446. doi: 10.1158/2767-9764.CRC-25-0334.
PubMed 41325133
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of CDK4/6 Inhibition (Palbociclib) Combined With PD-1 Blockade (INCMGA00012) in Patients With Advanced Well-differentiated Dedifferentiated Liposarcoma
- ClinicalTrials.gov ID
- NCT04438824
- Acronym / sponsor ID
- 20-062
- Keywords
- Palbociclib, INCMGA00012, 20-062
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Incyte Corporation
- Study start
- 17 Jun 2020 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 19 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The researchers are doing this study to find out whether combining the study drugs palbociclib and INCMGA00012 is an effective and safe treatment for advanced liposarcoma.
"Funding Source - FDA OOPD"
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a phase II study of palbociclib plus INCMGA00012 in patients with advanced WD/DD liposarcoma.
| Arm | Type | Receives |
|---|---|---|
| Palbociclib and INCMGA00012 | Experimental | Drug: INCMGA00012, Drug: PalbociclibInitial design (safety lead-in and expansion): One treatment cycle will consist of 28 days. Patients in both study phases will start palbociclib on Day 1 and INCMGA00012 on day 15 (+/- 7 days) of each cycle at the following dose schedule: INCMGA00012: 500 mg IV (flat dose) q28 days Palbociclib: 125 mg PO daily for 21 days, followed by 7 days off, q28 days Palbociclib will be taken on Day 1 of each cycle for 21 consecutive days followed by 7 days off (days 22-28 of each Cycle). INCMGA00012 will be administered on Day 15 of (+/- 7 days) each cycle and repeat every 28 days.(No longer using this) Amended design (Expansion only): One treatment cycle will consist of 28 days. Patients in both study phases will start palbociclib and INCMGA00012 on day 1 of each cycle: 500 mg IV (flat dose) of INCMGA00012 will be administered q28 days concurrently with palbociclib 125 mg PO daily for 21 days, followed by 7 days off, q28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- A diagnosis of metastatic or unresectable WD/DD liposarcoma. DD liposarcoma must be present. Unresectable is defined as if the primary tumor a) cannot be safely removed surgically or b) would benefit from systemic therapy prior to a surgical approach
- Measurable disease by RECIST 1.1
- Age ≥ 18 years
- ECOG performance status 0 or 1
- Adequate organ and marrow function as defined below (ULN indicates institutional upper limit of normal):
Key exclusion criteria (15 listed)
- Patients who have not recovered from clinically significant adverse events of prior therapy to ≤ NCI CTCAE v5 Grade 1, except alopecia and stable neuropathy, which must have resolved to Grade ≤ 2 or baseline.
- Patients receiving any other investigational agents.
- Patients who have received prior treatment with a selective CDK4 inhibitor or an anti-PD-1/PD-L1 agent
- Uncontrolled intercurrent illness including, but not limited to, known ongoing or active infection, including uncontrolled HIV, active hepatitis B or C, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmias, psychiatric illness/social situations that would limit compliance with study requirements, clinically significant interstitial lung disease or active noninfectious pneumonitis, or active infection requiring systemic therapy
- Pregnant women and women who are breast-feeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INCMGA00012INCMGA00012: 500 mg IV (flat dose) q28 days (+/- 7 days in each cycle) | Drug | Palbociclib and INCMGA00012 |
| PalbociclibPalbociclib:125 mg PO daily for 21 days, followed by 7 days off, q28 days | Drug | Palbociclib and INCMGA00012 |
Primary outcome
confirm the recommended phase two dose (RP2D
Time frame: within 6 weeks of treatment
DLTs will be assess within the first 6 weeks of the treatment combination . DLT definitions are described in section 15.4, and will be defined using NCI CTCAE v 5.0. If ≤ 1 patient out of 6 has a dose-limiting toxicity, the dosing used in the safety lead-in phase will be declared the recommended phase 2 dose. If ≥ 2 of 6 patients in the safety lead-in experience a DLT, study treatment will be halted and no further patients will be enrolled. If the study is resumed with an alternative dosing schema, a new safety lead-in phase will be completed with the new dosing regimen
best overall response rate (Phase II)
Time frame: by 48 weeks
defined by RECIST 1.1
2 secondary outcomes
Safety
Time frame: 2 years
overall response rate
Time frame: 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Derived from this study: PubMed 42082272Rosenbaum E, Seier K, Gularte-Merida R, Seffar E, Dickson MA, Avutu V, Banks LB, Chan JE, Chi P, Gounder MM, Kelly CM, Keohan ML, Maki RG, Movva S, Reed D, Desir R, Biniakewitz M, Cho JM, Duchemin M, Erinjeri JP, Lefkowitz RA, Koff A, Singer S, Tap W, Qin LX, D'Angelo S. Phase 2 study of palbociclib plus retifanlimab in patients with advanced dedifferentiated liposarcoma. J Immunother Cancer. 2026 May 4;14(5):e014346. doi: 10.1136/jitc-2025-014346.
- Derived from this study: PubMed 41325133Rosenbaum E, Gularte-Merida R, Seffar E, Lee J, Adamow M, Bradic M, Dickson MA, Avutu V, Banks LB, Chan JE, Chi P, Gounder MM, Kelly CM, Keohan ML, Maki RG, Movva S, Reed DR, Desir R, Biniakewitz M, Erinjeri JP, Lefkowitz RA, Wong P, Antonescu CR, Qin LX, Panageas KS, Shen R, Singer S, Koff A, Tap WD, D'Angelo SP. Tumor and Immune Dynamics Following Sequential CDK4/6 and PD-1 Inhibition: Results from a Phase 2 Study in Dedifferentiated Liposarcoma. Cancer Res Commun. 2026 Feb 1;6(2):437-446. doi: 10.1158/2767-9764.CRC-25-0334.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Related trials for Well-differentiated/Dedifferentiated Liposarcoma
RecruitingPhase 3
Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
Metastatic Dedifferentiated Liposarcoma, Metastatic Undifferentiated Pleomorphic Sarcoma
RecruitingPhase 1/2
A Study of Mirdametinib in Combination With Palbociclib in People With Liposarcoma
Well Differentiated Liposarcoma, Dedifferentiated Liposarcoma
RecruitingPhase 1/2
A Study to Efficacy and Safety of SPH4336 Monotherapy or in Combination With Cadonilimab in Patients With Advanced Solid Tumors.
Advanced Solid Tumors
RecruitingPhase 1/2
NRSTS2021, A Risk Adapted Study Evaluating Maintenance Pazopanib, Limited Margin, Dose-Escalated Radiation Therapy and Selinexor in Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS)
Adipocytic Neoplasm, Liposarcoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra D'Angelo, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing INCMGA00012 and Palbociclib in people with Well-differentiated/Dedifferentiated Liposarcoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
confirm the recommended phase two dose (RP2D (time frame: within 6 weeks of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04438824, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.