Is NCT04303117 recruiting in Bethesda, MD?

Yes, NCT04303117 is currently recruiting participants at its Bethesda, MD location. This kaposi sarcoma clinical trial is actively enrolling qualified participants.

How do I join the kaposi sarcoma clinical trial in Bethesda?

To join this clinical trial in Bethesda, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Bethesda clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Kaposi Sarcoma Clinical Trial in Bethesda, MD

About This Kaposi Sarcoma Study in Bethesda

Background: Kaposi sarcoma (KS) tumors grow on the skin, lymph nodes, lungs, bone, and gastrointestinal tract. KS often affects people with immune deficiencies, such as among people living with HIV or those with prior history of transplant. Researchers want to see if 2 non-chemotherapy drugs can help people with KS. PDS01ADC triggers the immune system to fight tumors. M7824 blocks the pathways that cancer cells use to stop the immune system from fighting tumors. Objective: To learn if giving PDS01ADC alone or with M7824 could help the immune system fight KS tumors. Eligibility: People 18 and older with KS that has been treated with chemotherapy or immunotherapy Design: Participants will be screened with some or all of the following: medical history physical exam chest X-ray computed tomography scan blood and urine tests electrocardiogram and echocardiogram skin KS lesion biopsy lung exam gastrointestinal exam All participants will get PDS01ADC every 4 weeks for up to 96 weeks (or 24cycles). It is injected under the skin. Some participants will also get M7824 every 2 weeks for up to 96 weeks (or 24cycles). It is given through a plastic tube that is put in an arm vein. Participants will complete questionnaires about how KS affects their quality of life. Their KS lesions will be measured and photographed. They will repeat some of the screening tests. They will give saliva samples or additional tissue samples. They will have a lung function test. Their ability to perform their normal activities will be assessed. The treatment duration is up to 96 weeks (or 24cycles) with an option to take PDS01ADC and/or M7824 until the KS tumors are not responding, or you develop unacceptable side effects. Participants will have follow-up visits 7 and 30 days after treatment ends, then every 3 to 6 months for the next 18 months, then once a year for 3 years.

Sponsor: National Cancer Institute (NCI)

Who Can Participate

Inclusion Criteria

Individuals with biopsy proven (confirmed in the Laboratory of Pathology \[LP\], CCR) Kaposi sarcoma (KS)

KS requiring systemic therapy, with or without history of prior KS therapy:

T1 KS or T0 KS sufficiently widespread that systemic therapy is advisable, or KS affecting quality-of-life due to local symptoms or psychological distress OR,

KS with an inadequate response to liposomal doxorubicin, paclitaxel, other systemic chemotherapy (either progressive disease or stable disease after 3 or more cycles) or immunotherapy (progressive disease)

A wash-out period off treatment of 2 weeks from last chemotherapy and 4 weeks from last immunotherapy, other systemic treatment with a biologic agent, or monoclonal antibody therapy will be required in individuals with prior KS therapy.

Resolution of toxicity from prior therapy to \<= Grade 1.

At least five measurable cutaneous KS lesions with no previous local radiation, surgical or intralesional cytotoxic therapy that would prevent response assessment for that lesion.

Measurable disease by the criteria proposed by the AIDS Clinical Trials Group (ACTG) Oncology Committee for KS

HIV positive or negative.

ART for HIV+ individuals for 8 or more weeks prior to entry with an HIV viral load of \<400 copies/ml at screening and CD4+ T cell count of \>= 50 cells/microliter as this may be expected if individuals have received several courses of chemotherapy.

Age \>=18 years.

ECOG performance status \<=2 (Karnofsky \>=60%).

Adequate organ and marrow function as defined below:

Absolute neutrophil count \>=1,000/mcL

Platelets \>=100,000/mcL

Total bilirubin within normal institutional limits; OR \<3x institutional upper limit of normal (ULN) for Gilbert s syndrome or HIV protease inhibitors; OR \<5x ULN and direct bilirubin \< 0.7mg/dL for individuals on atazanavir-containing HIV regimen

AST/ALT \<=1.5 X institutional ULN

Hemoglobin \>= 9g/dL

Creatinine within normal institutional limits OR creatinine clearance \>30 mL/min/1.73m\^2 as estimated by either Cockroft-Gault of 24- hour urine collection if creatinine levels above institutional normal

Normal international normalized ratio (INR), prothrombin time (PT) \<= 1.5 x ULN, and activated partial thromboplastin time (aPTT) \<= 1.5 x ULN (required only if participants will receive M7824)

The effects of PDS01ADC and M7824 on the developing human fetus are unknown. For this reason, women of child-bearing potential (WOCBP) and individuals able to father a child must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, during treatment and for at least 4 months after the last dose of treatment and agree to inform the treating physician immediately if they become pregnant. Also, there is unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with M7824 and/or PDS01ADC, therefore WOCBP must agree to discontinue nursing if treated with these agents.

Ability of individual to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

Receiving any other investigational agents.

Pregnant individuals are excluded from this study as the effects of PDS01ADC and M7824 have potential teratogenic or abortifacient effects.

Severe KS (such as symptomatic pulmonary KS) that could be life threatening if it progressed over 2-4 weeks

Actively bleeding sites caused by visceral KS.

Unwilling to accept blood products as medically indicated

Actively bleeding and/or requiring transfusions in the 2 weeks preceding study entry.

History of bleeding, diathesis, or recent major bleeding events within a period of 4 weeks considered by the investigator as high risk for investigational drug treatment.

Any active or recent history (symptomatic in the last 3 months) of a known or suspected autoimmune disease (with the exception of diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment) or recent history of a syndrome that required systemic corticosteroids (10mg daily prednisone or equivalent) or immunosuppressive medications except inhaled steroids and adrenal replacement steroids doses up to 10mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.

Uncontrolled opportunistic infections

Active multicentric Castleman disease

Individuals with primary effusion lymphoma

History of malignant tumors other than KS, unless:

In complete remission for \>= 3 years from the time complete remission was first documented or

Resected basal cell or squamous cell carcinoma of the skin or

In situ cervical or anal dysplasia

History of allergic reactions attributed to compounds of similar chemical or biologic composition to PDS01ADC and/or M7824 investigational agents used in study.

Active tuberculosis (TB):

Individuals who are undergoing first month of therapy (RIPE or equivalent) for active TB or

Individuals with TB immune reconstitution syndrome (IRIS) requiring corticosteroids

Received or will receive a live vaccine within 30 days prior to the first administration of study intervention. Seasonal flu vaccines that do not contain a live virus are permitted. Locally approved COVID vaccines are permitted.

Uncontrolled substantial intercurrent illness including, but not limited to, ongoing or active severe infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, that would limit compliance with study requirements.

Medical or psychiatric illness or social situation that would, in the opinion of the investigator, preclude participation in the study or the ability of individuals to provide informed consent for themselves.

Uncontrolled HBV infection, defined as plasma HBV DNA detectable by PCR Note: the following will NOT be exclusionary:

A positive hepatitis B serology indicative of previous immunization (i.e. HbsAb positive and HbcAb negative), or a fully resolved acute HBV infection

Chronic HBV suppressed by appropriate antiretroviral therapy with activity against HBV, as outlined in DHHS guidelines.

Uncontrolled HCV infection, defined as plasma HCV DNA detectable by PCR Note: the following will NOT be exclusionary:

Positive HCV serology but no detectable HCV RNA, indicative of spontaneously cleared HCV infection

Successfully treated for HCV as long as therapy for HCV has been completed. -Individuals will be excluded from the combination therapy arm if:

they have discontinued prior PD1/L1 blocking agent due to immune mediated adverse event(s) OR

they have active non-infectious pneumonitis or a history of steroid requiring non-infectious pneumonitis.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Bethesda?

Yes, this clinical trial (NCT04303117) has an active research site in Bethesda, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Kaposi Sarcoma Treatment Options in Bethesda, MD

If you're searching for kaposi sarcoma treatment options in Bethesda, MD, this clinical trial (NCT04303117) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Bethesda research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced kaposi sarcoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all kaposi sarcoma clinical trials near you to find additional studies recruiting in your area.

Kaposi Sarcoma Clinical Trial in Bethesda, MD

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