Ended Phase I and Phase II (Integrated)- Other Immune related adverse events induced by treatment with immunotherapy

Extracorporeal photopheresis as treatment for immune related adverse events after immunotherapy

EU CTIS ID: 2024-513614-36-00

What this study is testing

Our preliminary data demonstrate that irAEs induced by immune checkpoint blockade can be successfully treated with ECP (Apostolova et al. NEJM 2020). We therefore intend to launch a clinical phase 1/2 trial to validate this finding in a prospective trial. The primary objective is evaluation of safety of ECP treatment in patients with irAEs.

Phase I and Phase II (Integrated)- Other

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

1. Male and female patients aged ≥18 years with adequate German written and oral language skills
2. Written informed consent: • Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. • Subjects must be able to understand and willing to comply with scheduled visits, treatment schedule, laboratory tests and mandatory collection of blood, and other requirements of the study. • Subject Re-enrollment: This trial permits the re-enrollment of a subject that has discontinued the study as a screening failure. If reenrolled, the subject must be re-consented.
3. Target population • Patients who have received treatment with an anti-PD-1, anti-PD-L1 or an anti-CTLA-4 antibody or any combination of these for any type of malignancy in the last 24 months before screening. 30% of the patients that will be included should have non-skin cancer. • Patients should have clinical and/or histological evidence of immunerelated adverse events as follows: o Colitis: Diarrhea with increase of ≥4 stools over baseline; No improvement after 72h treatment with at least 1 mg/kg BW/day prednisolone equivalent o o Hepatitis  Alanine aminotransferase and/or aspartate aminotransferase ≥3x ULN if baseline was normal; or ≥3x baseline if baseline was abnormal and/or total bilirubin >1.5 ULN.  No improvement after 72h treatment with at least 1 mg/kg BW/day prednisolone equivalent o Pneumonitis  Radiographic changes that involve more than one lobe of the lung or ≥25% of lung parenchyma and new symptoms such as cough, dyspnea or chest painor new oxygen therapy  No improvement after 72h treatment with 1 mg/kg BW/day prednisolone equivalent o Dermatitis  Skin erythema, maculopapular or pustulopapular rRash covering >≥ 30% of the body surface area and moderate or severe symptoms  No improvement after
4. Maximum of one additional (second line) therapy after Steroid treatment before ECP starts (e.g. infliximab for colitis)
5. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 1 week prior to the start of study drug. Males who are sexually active with WOCBP must use during the duration of the study and up to 5 months afterwards a latex or synthetic condom during any sexual contact with females of reproductive potential, even if they have undergone a successful vasectomy (see also 10.9). Patients must abstain from donating blood, semen, or sperm during participation in the study
6. Women must not be breastfeeding.

You likely can't join if

1. Active treatment in a clinical study of any investigational agent within 14 days prior day 0 or within 5 half-lives of the study treatment, whichever is greater.
10. Aphakia
11. Sexually active men and female patients of child-bearing potential who are not willing to use highly effective methods of contraception during the trial and at least 5 months after the last ECP procedure (see also 10.9)
12. Inability to tolerate extracorporeal volume loss
13. Previous splenectomy
14. Pregnancy and lactation

See the full eligibility criteria

Who can join

1. Male and female patients aged ≥18 years with adequate German written and oral language skills
2. Written informed consent: • Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. • Subjects must be able to understand and willing to comply with scheduled visits, treatment schedule, laboratory tests and mandatory collection of blood, and other requirements of the study. • Subject Re-enrollment: This trial permits the re-enrollment of a subject that has discontinued the study as a screening failure. If reenrolled, the subject must be re-consented.
3. Target population • Patients who have received treatment with an anti-PD-1, anti-PD-L1 or an anti-CTLA-4 antibody or any combination of these for any type of malignancy in the last 24 months before screening. 30% of the patients that will be included should have non-skin cancer. • Patients should have clinical and/or histological evidence of immunerelated adverse events as follows: o Colitis: Diarrhea with increase of ≥4 stools over baseline; No improvement after 72h treatment with at least 1 mg/kg BW/day prednisolone equivalent o o Hepatitis  Alanine aminotransferase and/or aspartate aminotransferase ≥3x ULN if baseline was normal; or ≥3x baseline if baseline was abnormal and/or total bilirubin >1.5 ULN.  No improvement after 72h treatment with at least 1 mg/kg BW/day prednisolone equivalent o Pneumonitis  Radiographic changes that involve more than one lobe of the lung or ≥25% of lung parenchyma and new symptoms such as cough, dyspnea or chest painor new oxygen therapy  No improvement after 72h treatment with 1 mg/kg BW/day prednisolone equivalent o Dermatitis  Skin erythema, maculopapular or pustulopapular rRash covering >≥ 30% of the body surface area and moderate or severe symptoms  No improvement after
4. Maximum of one additional (second line) therapy after Steroid treatment before ECP starts (e.g. infliximab for colitis)
5. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 1 week prior to the start of study drug. Males who are sexually active with WOCBP must use during the duration of the study and up to 5 months afterwards a latex or synthetic condom during any sexual contact with females of reproductive potential, even if they have undergone a successful vasectomy (see also 10.9). Patients must abstain from donating blood, semen, or sperm during participation in the study
6. Women must not be breastfeeding.
7. ECOG performance status 0, 1, or 2

What rules you out

1. Active treatment in a clinical study of any investigational agent within 14 days prior day 0 or within 5 half-lives of the study treatment, whichever is greater.
10. Aphakia
11. Sexually active men and female patients of child-bearing potential who are not willing to use highly effective methods of contraception during the trial and at least 5 months after the last ECP procedure (see also 10.9)
12. Inability to tolerate extracorporeal volume loss
13. Previous splenectomy
14. Pregnancy and lactation
2. Positive result for HIV.
3. Active COVID-19-infection or non-compliance with the prevailing hygiene measures regarding the COVID-19 pandemic
4. Prior allogeneic bone marrow transplantation or prior solid organ transplantation.
5. Patients who require vasopressors, and/or have NYHA class III or IV heart failure.
6. Uncontrolled hypertension or ventricular arrhythmias.
7. Previous or concurrent malignancies within the last 3 years of enrollment other than the disease for which checkpoint-inhibitor blockade was applied. Exceptions are adequately treated basal or squamous cell skin cancer, or any other cancer from which the subject has been disease-free for more than 3 years.
8. Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study data
9. Known allergies, hypersensitivity, or intolerance of methoxypsoralen, excipients, or similar compounds, acid-citrate-dextrose or similar compounds

The study team makes the final eligibility decision.

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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.