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SarcomaPhase 2NCT03798106

A Study of Pazopanib and Durvalumab for Metastatic Soft Tissue Sarcoma

A Phase 2 study testing Durvalumab, pazopanib in people with Sarcoma, run by Yonsei University at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Pazopanib is an angiogenesis inhibitor targeting VEGFR-1, -2, and -3; PDGFR-α and -β; and the receptor c-Kit, and is indicated for the treatment of subjects with advanced renal cell carcinoma (RCC) and advanced STS. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Sarcoma
What is being tested?
Durvalumab, pazopanib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteSouth Korea
Study dates
10 Apr 2019to 10 Aug 2022
Phase
Phase 2
Are there results?
None posted in the registry

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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed STS progression to 1 or 2 prior chemotherapy
  • Age > 18 years at time of study entry.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Measurable disease by Response Evaluation Criteria in Solid Tumors Version 1.1
  • Body weight >30kg
  • Adequate laboratory findings
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  • Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients.
  • Patient is willing and able to comply with the protocol for the duration of the study
  • Must have a life expectancy of at least 12 weeks
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
  • Patients with evidence of portal hypertension (including splenomegaly detected radiographically) or any prior history of variceal bleeding must have had endoscopic evaluation within the 3 months immediately prior to enrollment, and the findings do not represent a high bleeding risk.

Who cannot join

  • More than 4 prior cytotoxic regimens
  • Participation in another clinical study with an investigational product during the last 2 weeks
  • Receipt of the last dose of anticancer therapy 14 days prior to the first dose of study drug
  • Any previous treatment with a PD1 or PD-L1 inhibitor (including durvalumab) and/or pazopanib
  • Mean QT interval corrected for heart rate (QTc) >480 ms calculated from 3 electrocardiograms (ECGs) using Fridericia's Correction
  • Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
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  • Any concurrent chemotherapy, biologic, or hormonal therapy for cancer treatment within 2 weeks prior to entering the study. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable
  • Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug
  • Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.
  • History of allogenic organ transplantation.
  • Active or prior documented autoimmune or inflammatory disorders
  • Uncontrolled intercurrent illness
  • History of active infection
  • History of another primary malignancy
  • History of leptomeningeal carcinomatosis who are neurologically unstable or have required active treatment
  • Receipt of live attenuated vaccine within 30 days prior to the first dose of investigational product(IP).
  • Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose.
  • Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
  • No history of any of the following in the past 6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery bypass graft surgery, symptomatic peripheral vascular disease class III or IV congestive heart failure, as defined by the New York Heart Association), thromboembolic events

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

Other trials in South Korea

About this study

Official title: A Phase II Trial of Pazopanib and Durvalumab for Metastatic Soft Tissue Sarcoma

Pazopanib is an angiogenesis inhibitor targeting VEGFR-1, -2, and -3; PDGFR-α and -β; and the receptor c-Kit, and is indicated for the treatment of subjects with advanced renal cell carcinoma (RCC) and advanced STS. For this orphan tumor, STS, PD-L1 targeting may be a promising strategy and favorable toxicity may warrant further combination.

Read the detailed description

Pazopanib is an angiogenesis inhibitor targeting VEGFR-1, -2, and -3; PDGFR-α and -β; and the receptor c-Kit, and is indicated for the treatment of subjects with advanced renal cell carcinoma (RCC) and advanced STS. Pro-angiogenic factors suppress various immune functions whereas antiangiogenic agents have potential to modulate the tumor microenvironment and improve immunotherapy. An analysis of patients with RCC treated with pazopanib demonstrated that elevated expression of PD-L1 correlates with shorter PFS. Investigator also identified 43% of PD-L1 expression in STS and PD-L1 expression had worse overall survival (5-year survival rate: 48% in PD-L1 positive vs. 68% in PD-L1 negative, p=0.015). In detail, PD-L1 expression was reported 52.6% in synovial sarcoma, 37.6% in rhabdomyosarcoma, and 100% in epithelioid sarcoma. For this orphan tumor, STS, PD-L1 targeting may be a promising strategy and favorable toxicity may warrant further combination.

Conditions
Sarcoma
Being tested
Durvalumab, pazopanib
Medical subject headings
Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Durvalumab, pazopanibDrug

    Durvalumab 1500mg IV 1hr q3weeks Pazopanib 800mg QD PO q3wwks

Study groups in NCT03798106
Study groupRoleWhat they receive
durvalumab+pazopanibExperimentalDurvalumab 1500mg IV 1hr q3weeks Pazopanib 800mg QD PO q3wwks
Receives: Drug: Durvalumab, pazopanib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate

    antitumor efficacy of durvalumab and pazopanib

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2019
  2. Study start10 Apr 2019
  3. Primary completion10 Aug 2022
  4. Study completion10 Aug 2022

Resources

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
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03798106
Sponsor's protocol ID
4-2018-0743
Status last verified
Jun 2023
First submitted
7 Jan 2019
Last updated
12 Jun 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cho HJ, Yun KH, Shin SJ, Lee YH, Kim SH, Baek W, Han YD, Kim SK, Ryu HJ, Lee J, Cho I, Go H, Ko J, Jung I, Jeon MK, Rha SY, Kim HS. Durvalumab plus pazopanib combination in patients with advanced soft tissue sarcomas: a phase II trial. Nat Commun. 2024 Jan 23;15(1):685. doi: 10.1038/s41467-024-44875-2.

    PubMed 38263321

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Durvalumab, pazopanib in people with Sarcoma, run by Yonsei University at 1 site in South Korea.

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 11 inclusion and 19 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: finished, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Objective Response Rate (time frame: 12 weeks). 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 NCT03798106, which also lists 1 linked publication.

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 12 Jun 2023.

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