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Ovarian CancerPhase 2NCT05467670

Safety and Efficacy of Anti-CD47, ALX148 in Combination With Liposomal Doxorubicin and Pembrolizumab in Recurrent Platinum-resistant Ovarian Cancer

A Phase 2 study testing Pembrolizumab, ALX148 and Doxorubicin in people with Ovarian Cancer, run by Alexander B Olawaiye, MD at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Immunotherapy with immune checkpoint inhibitors, including pembrolizumab, have emerged as a promising option in several solid cancers with durable effect and low toxicity profile. However, the benefit is limited to smaller subset of solid tumors. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Pembrolizumab, ALX148 and Doxorubicin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
30 Mar 2023to 13 Apr 2029
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must have recurrent epithelial ovarian cancer.
  • Platinum-resistant disease: Patients who recur within < 6 months of prior platinum-based therapy excluding those with primary platinum refractory disease (see exclusion criteria).
  • Following histology types are acceptable: high grade serous or high grade endometrioid, clear cells, high grade translational cell, poorly differentiated or undifferentiated carcinomas, mixed histology (including one of above histology).
  • 0-3 prior lines in platinum-resistant setting.
  • Known BRCA status or willing to be tested.
  • Up to 5 prior lines of therapy are allowed.
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  • Participants must have measurable disease based on RECIST 1.1 with at least one target lesion.
  • Participants must have an ECOG performance status of 0-1.
  • Participants must be female, Age >18 years. Because no dosing or AE data are currently available on the use of pembrolizumab in combination with ALX148 in participants ≤18 years of age, children are excluded from this study.
  • Participants must have normal organ and marrow function as defined below within 14 days of enrollment unless otherwise indicated.
  • Participants must have the ability to understand and the willingness to sign a written informed consent document.
  • Negative serum or urine pregnancy test at screening for women of childbearing potential.
  • Willing to use highly effective contraception throughout the study and for at least 4 months after last treatment administration if childbearing potential exists.
  • Availability of an archival FFPE tumor tissue block from primary diagnosis specimen, metastatic, or recurrent site. If an FFPE tissue block cannot be provided then 15 unstained slides (10 microns, 10 slides minimum) will be acceptable. Please refer to the laboratory manual for complete details.

Who cannot join

  • Patients with sarcoma or carcinosarcoma or low-grade carcinoma.
  • Patients with primary platinum-refractory carcinoma who progressed while on or within 3 months of primary platinum-based combination therapy at first line setting.
  • Prior systemic anti-cancer therapy including investigational agents within 4 weeks [can be in follow-up phase of prior study and could consider shorter interval for kinase inhibitors or other short half-life drugs] prior to [randomization /allocation]. AEs due to previous therapies will be evaluated for eligibility. Recovery from complications due to prior must be adequate.
  • Prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
  • Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.
  • Known symptomatic brain metastases requiring steroids. Patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to study enrollment, have discontinued corticosteroid treatment for these metastases for at least 4 weeks and are neurologically stable with no evidence of disease progression for 3 months.
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  • Patients having received prior therapy with PD1, PDL1, CTLA4 inhibitors, CD47 or SIRP1- α inhibitors or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137), or other immunotherapeutic agents.
  • Prior therapy with PLD. Patients who received PLD in combination with platinum in platinum sensitive setting are allowed if they had initial objective complete response and PLD-platinum free interval of 6 months or more.
  • Active autoimmune disease that might deteriorate when receiving an immune-stimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible.
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing ≥ 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
  • Has active autoimmune disease that has required systemic treatment in the past 2 years (with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
  • Patients currently on immunosuppressive therapy except: intra-nasal, inhaled, topical or local steroid injections, steroids as premedication, systemic corticosteroids ≤10 mg/day of prednisone or equivalent
  • Patients who are pregnant or breast feeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.
  • Known history of immune-mediated colitis, inflammatory bowel disease, pneumonitis ((non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease), pulmonary fibrosis.
  • Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.
  • Individuals with a history of a different malignancy 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 3 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 underwent potentially curative therapy: breast cancer in situ, cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin. Patients with a history of carcinoma in situ of the bladder are excluded.
  • Prior organ transplantation including allogenic stem-cell transplantation.
  • Active infection requiring intravenous systemic therapy. Oral antibiotic therapy is allowed.
  • Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection.
  • Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority or treating physician per standard of care except patients with a known history of Hepatitis B not on a stable dose of antiviral therapy, with HBV viral load below the limit of quantification. HCV viral load below the limit of quantification.
  • History of infection with (screening tests not required) human immunodeficiency virus; except following situation:
  • HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of enrollment are eligible for this trial.
  • Received live or live-attenuated vaccine within 4 weeks of the first dose of treatment and while on trials is prohibited except for administration of inactivated vaccines. Influzena and COVID vaccinations are permissible.
  • Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v5 Grade ≥ 3).
  • Persistent toxicity related to prior therapy (NCI CTCAE v. 5 Grade > 1); however, alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable.
  • Other severe acute or chronic medical conditions including immune colitis, inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
  • A WOCBP who has a positive urine pregnancy test within 72 hours prior to [randomization/allocation] (see Appendix IV). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

Other trials in United States

About this study

Official title: Safety and Efficacy of Anti-CD47, ALX148 in Combination With Liposomal Doxorubicin and Pembrolizumab in Patients With Recurrent Platinum-resistant Ovarian Cancer: Phase II Study

Immunotherapy with immune checkpoint inhibitors, including pembrolizumab, have emerged as a promising option in several solid cancers with durable effect and low toxicity profile. However, the benefit is limited to smaller subset of solid tumors. This trial involves the enhancement of current immune checkpoint-based immunotherapy with ALX148, an agent that inhibits CD47 (a trans-membrane protein that is highly expressed on the surface of many solid tumors as compared to normal cells).

Read the detailed description

All patients on this study will receive Pegylated Liposomal Doxorubicin (PLD) as standard of care combined with pembrolizumab and ALX148 iv every 21 days. Treatment of 45 mg/kg Q3W ALX148 in combination with pembrolizumab + chemotherapy will continue until disease progression or unacceptable grade 3/4 toxicities. For patients with a complete response to therapy, maintenance therapy with pembrolizumab and ALX148 will be continued for 12 months. Patients will have up to 4 weeks of screening, and will be treated until disease progression, patient withdraws consent, unacceptable toxicity occurs, complete response or the study is terminated. Patients may continue treatment after radiographic progression if, in the judgment of the treating investigator the patient is deriving clinical benefit from study treatment by demonstrating an absence of clinical symptoms or signs indicating clinically significant disease progression; no decline in performance status; absence of rapid disease progression or threat to vital organs or critical anatomical sites. A follow-up visit will occur within between 28 days and 35 days after the last treatment.

Conditions
Ovarian Cancer
Being tested
Pembrolizumab, ALX148, Doxorubicin
Keywords
anti-CD47 therapy, platinum resistance, macrophage mediated phagocytosis, checkpoint inhibitors
Medical subject headings
Ovarian Neoplasms

What participants receive

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

  • PembrolizumabDrug

    Also called Keytruda®

    A type of immunotherapy that stimulates the body's immune system to fight cancer cells by targeting and blocking PD-1 proteins on the surface of certain immune T-cells, thus triggering the T-cells to find and kill cancer cells.

  • ALX148Drug

    Also called evorpacept

    A fusion protein comprised of a high affinity CD47 blocker linked to an inactive immunoglobulin Fc region, enhancing innate and adaptive immune responses against cancer.

  • DoxorubicinDrug

    Also called (Pegylated Liposomal Doxorubicin (PLD)

    An anthracycline that slows/stops the growth of cancer cells by blocking an enzyme called topo isomerase 2, used as second line non-platinum chemotherapy in patients with platinum-resistant ovarian cancer.

Study groups in NCT05467670
Study groupRoleWhat they receive
ALX148 + Doxorubicin (PLD) + PembrolizumabExperimentalGiven on Day 1 of each 21 day cycle, in the following order of administration: 200 mg IV pembrolizumab* (maximum of 2 years (approximately 35 cycles) 45 mg/kg IV ALX148 30 mg/m^2 IV doxorubicin (Pegylated Liposomal Doxorubicin (PLD)* *standard of care
Receives: Drug: Pembrolizumab; Drug: ALX148; Drug: Doxorubicin

What is being measured

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

  1. Objective Response Rate (ORR)

    The proportion of patients having either a complete response (CR) or partial response (PR), per RECIST 1.1. Complete Response (CR): Disappearance of all target lesions. For non-target lesions, CR is the disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

    Measured: Up to 3 years (cohort)

Secondary outcomes (4)

  1. Overall Survival (OS)

    The number of months from the date of study enrollment until date of death ( from any cause) or last known date of follow up if otherwise lost to follow up.

    Measured: Up to 5 years

  2. Progression-free survival (PFS)

    The number of months from the date of study enrollment to the date of an event of disease progression (per RECIST 1.1) or to the date of death from any cause. Progressive Disease (PD) as defined by RECIST v1.1 for target lesions: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. For non-target lesions: Appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

    Measured: Up to 5 years

  3. Objective response rate Immune-related Response Criteria (iRECIST)

    The proportion of patients with complete or partial response per iRECIST. irCR (Complete Response):Disappearance of non-nodal lesions. All pathologic lymph nodes <10 mm (2 consecutive measures ≥4 weeks apart); irPR (Partial Response):≥30% decrease from baseline (2 consecutive measures ≥4 weeks apart); All pathologic lymph nodes <10 mm (Non-Target Lesions: Any other than disappearance of all non-nodal lesions and reduction of pathologic lymph nodes <10 mm). Baseline tumor burden: sum of single diameters (short axis for nodal lesions, longest diameter for other lesions) for target lesions. In subsequent scans, the diameters of new measurable lesions are added to the tumor burden. Re-treatment: ≤5 target lesions (=/≠ original lesions) are selected and a new baseline tumor burden will be established.

    Measured: Up to 3 years (cohort)

  4. Duration of response (DOR)

    The number of months from the date of study enrollment to the date of disease progression or death in those participants who achieve complete or partial response per RECISIT 1.1. Complete Response (CR): Disappearance of all target lesions. For non-target lesions, CR is the disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD) for target lesions: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. For non-target lesions: Appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change not a single lesion increase.

    Measured: Up to 3 years (cohort); at 12 weeks (patient)

Timeline

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

  1. First posted20 Jul 2022
  2. Study start30 Mar 2023
  3. Primary completion13 Apr 2026
  4. Study completion13 Apr 2029 (estimated)

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
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05467670
Sponsor's protocol ID
HCC 21-193
Status last verified
Jul 2026
First submitted
12 Jul 2022
Last updated
21 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab, ALX148 and Doxorubicin in people with Ovarian Cancer, run by Alexander B Olawaiye, MD at 1 site 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 14 inclusion and 27 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 21 Jul 2026. 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 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?

Objective Response Rate (ORR) (time frame: Up to 3 years (cohort)). 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 NCT05467670.

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 21 Jul 2026.

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Clinical Trial NCT05467670 | AzTrials