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New treatment option for Kaposi Sarcoma
Official title PDS01ADC Monotherapy and in Combination With M7824 in Advanced Kaposi Sarcoma
ClinicalTrials.gov ID: NCT04303117
What this study is testing
What is PDS01ADC?
PDS01ADC is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for kaposi sarcoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 96 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- 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...
- KS with an inadequate response to liposomal doxorubicin, paclitaxel, other systemic chemotherapy (either progressive disease or stable disease after...
- A wash-out period off treatment of 2 weeks from last chemotherapy and 4 weeks from last immunotherapy, other systemic treatment with a biologic...
You likely can't join if
- 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.
See the full eligibility criteria
Who can join
- 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...
- 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 \ = 50 cells/microliter as this may be expected if individuals have received several courses of chemotherapy.
- Age \>=18 years.
- ECOG performance status \ =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...
- 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...
- Ability of individual to understand and the willingness to sign a written informed consent document.
What rules you out
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 96 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.